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VOLUME 





OF INFECTION CONTROL AND EPIDEMIOLOGY 


4th edition 


TROPIC 










TABLE OF CONTENTS 


VOLUME I 

Acknowledgements 
Editors 
Authors 
Reviewers 
Production Staff 

Declarations of Conflicts of Interest 
Preface 

Section 1. Overview of Infection Prevention 
Programs 

1. Infection Prevention and Control Programs 

2. Competency and Certification of the Infection 
Preventionist 

3. Education and Training 

4. Accrediting and Regulatory Agencies 

5. Infection Prevention and Behavioral Interventions 

6. Healthcare Informatics and Information Technology 

7. Product Evaluation 

8. Legal Issues 

9. Staffing 

Section 2. Epidemiology, Surveillance, 
Performance, and Patient Safety Measures 

10. General Principles of Epidemiology 

11. Surveillance 

12. Outbreak Investigations 

13. Use of Statistics in Infection Prevention 

14. Process Control Charts 

15. Risk-adjusted Comparisons 

16. Quality Concepts 

17. Performance Measures 

18. Patient Safety 

19. Qualitative Research Methods 

20. Research Study Design 

Section 3. Microbiology and Risk Factors for 
Transmission 

21. Risk Factors Facilitating Transmission of Infectious 
Agents 

22. Microbial Pathogenicity and Host Response 

23. The Immunocompromised Host 

24. Microbiology Basics 

25. Laboratory Testing and Diagnostics 

26. Antimicrobials and Resistance 


Section 4. Basic Principles of Infection Prevention 
Practice 

27. Hand Hygiene 

28. Standard Precautions 

29. Isolation Precautions (Transmission-based 
Precautions) 

30. Aseptic Technique 

31. Cleaning, Disinfection, and Sterilization 

32. Reprocessing Single-use Devices 

VOLUME II 

Section 5. Prevention Measures for Healthcare- 
Associated Infections 

33. Urinary Tract Infection 

34. Intravascular Device Infections 

35. Infections in Indwelling Medical Devices 

36. Pneumonia 

37. Surgical Site Infection 

Section 6. Infection Prevention for Specialty Care 
Populations 

38. Burns 

39. Dialysis 

40. Geriatrics 

41. Neonates 

42. Pediatrics 

43. Perinatal Care 

44. Infection Prevention in Oncology and Other 
Immunocompromised Patients 

45. Solid Organ Transplantation 

46. Hematopoietic Stem Cell Transplantation 

47. Nutrition and Immune Function 

Section 7. Infection Prevention for Practice 
Settings and Service-Specific Patient Care Areas 

48. Ambulatory Care 

49. Behavioral Health 

50. Cardiac Catheterization and Electrophysiology 

51. Correctional Facilities 

52. Child Care Services 

53. Dental Services 

54. Emergency and Other Prehospital Medical Services 

55. Endoscopy 



56. Home Care 

57. Hospice and Palliative Care 

58. Imaging Services and Radiation Oncology 

59. Intensive Care 

60. Interventional Radiology 

61. Long-term Care 

62. Long-term Acute Care 

63. Ophthalmology Services 

64. Ambulatory Surgery Centers 

65. Postmortem Care 

66. Rehabilitation Services 

67. Respiratory Care Services 

68. Surgical Services 

Volume III 

Section 8. Healthcare-Associated Pathogens and 
Diseases 

69. Xenotransplantation 

70. Biofilms 

71. BordeteUa pertussis 

72. Clostridium difficile Infection and 
Pseudomembranous Colitis 

73. Creutzfeldt-Jakob Disease and other Prion Diseases 

74. Central Nervous System Infection 

75. Enterobacteriaceae 

76. Enterococci 

77. Environmental Gram-negative Bacilli 

78. Fungi 

79. A. Diarrheal Diseases: Viral 

B. Diarrheal Diseases: Bacterial 

C. Diarrheal Diseases: Parasitic 

80. Herpes Virus 

81. HIV/AIDS 

82. Influenza 

83. Foodborne Illnesses 

84. Legionella pneumophila 

85. Lyme Disease (Borrelia burgdorferi) 

86. Measles, Mumps, Rubella 

87. Neisseria meningitidis 

88. Parvovirus 

89. Rabies 

90. Respiratory Syncytial Virus 

91. Sexually Transmitted Diseases 

92. Skin and Soft Tissue Infections 

93. Staphylococci 

94. Streptococci 


95. Tuberculosis and Other Mycobacteria 

96. Viral Hemorrhagic Fevers 

97. Viral Hepatitis 

98. West Nile Virus 

99. Parasites 


Section 9. Infection Prevention for Occupational 
Health 

100. Occupational Health 

101. Occupational Exposure to Bloodborne Pathogens 

102. Volunteers, Contract Workers, and Other 
Nonemployees Who Interact with Patients 

103. Immunization of Healthcare Personnel 

104. Pregnant Healthcare Personnel 

105. Minimizing Exposure to Blood and Body Fluids 

Section 10. Infection Prevention for Support 
Services and the Care Environment 

106. Sterile Processing 

107. Environmental Services 

108. Laboratory Services 

109. Nutrition Services 

110. Pharmacy Services 

111. Laundry, Patient Linens, Textiles, and Uniforms 

112. Maintenance and Engineering 

113. Waste Management 

114. Heating, Ventilation, and Air Conditioning 

115. Water Systems Issues and Prevention of Waterborne 
Infectious Diseases in Healthcare Facilities 

116. Construction and Renovation 

Section 11. Community-based Infection Prevention 
Practices 

117. Public Health 

118. Travel Health 

119. Emergency Management 

120. Infectious Disease Disasters: Bioterrorism, Emerging 
Infections, and Pandemics 

121. Animal Research and Diagnostics 

122. Animals Visiting Healthcare Facilities 

123. Body Piercing, Tattoos, and Electrolysis 

Index 


VI 


APIC Text of Infection Control and Epidemiology 



VOLUME I 



Section 1 

Overview of Infection Prevention Programs 



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APIC 

XnVT OF INFECTION CONTROL 
! tA I AND EPIDEMIOLOGY 


Infection Prevention and Control Programs 


Authors): Candace Friedman, MPH, CIC 

Project Manager/Office of Clinical Safety 

University of Michigan Hospitals and Health System 
Ann Arbor, Ml 

Published: November 26, 2014 


Abstract 

Infection prevention and control programs in the United States have changed significantly since the mid- 
20th century. Much of this change was a result of the influence of professional and nonprofit 
organizations; government, regulatory, and accrediting agencies; and scientific research and 
publications. Other influences include increasing acuity of patients, aging of the population, complexity 
and location of treatment interventions, and the increasing move toward care in home/ambulatory 
settings. There are various models outlined for infection prevention and control programs and standards 
developed for infection prevention professionals. This chapter includes information on Health and Human 
Services activities, the National Healthcare Safety Network, and information on international infection 
prevention and control programs. 

Key Concepts 

• Infection prevention and control programs have evolved significantly over the past 50 years. 

• Infection prevention and control programs are affected by professional and nonprofit organizations; 
government, regulatory, and accrediting agencies; and scientific research and publications. 

• An infection prevention team is an important component of the infection prevention and control 
program. 

Background 

The first infection prevention and control efforts in the United States began in hospitals in the 1950s 
concurrent with the growth of intensive care and increasing staphylococcal infections.ilnfection 


prevention and control programs extended into thousands of hospitals in the late 1960s and 1970s in 

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response to urging from various organizations (e.g., American Hospital Association [AHA] and The Joint 
Commission [TJC]). 

In the decades since the 1970s, changes to these programs have occurred as a result of state and 
federal agencies, professional and nonprofit organizations, and scientific information published in 
journals. The 21st century brought increased attention to infection prevention and control programs 
because of government interest and oversight and activities of patient safety organizations. Other 
influences on programs include increasing acuity of patients, aging of the population, complexity and 
location of treatment interventions, and the increasing move toward care in home/ambulatory settings. 

One major influence is the Department of Health and Human Services' road map for healthcare- 
associated infections (HAI) elimination outlined in 2008. It focused on broad programs to significantly 
reduce harm in hospitals and improve care across healthcare settings. 2 Elimination of HAIs requires a 

culture change for healthcare personnel (HOP) in which no infection is perceived as acceptable by any 
member of the healthcare team—support and direction from senior leadership is essential.sThis support 

includes implementation of evidence-based practices, alignment of financial incentives, research, 
acquiring pertinent information, and accountability. 

In addition, changes in the healthcare industry over the past few decades have placed increased 
demands on infection prevention and control programs. There are various quality improvement/patient 
safety activities focused on HAI reduction, including value-based purchasing, evidence-based practice 
centers, use of technology, implementing a culture of safety, and public reporting of data.4, 5, 6Public 

reporting, pay-for-performance, and reduced payment for hospital-acquired conditions have increased 
the focus on infection prevention. 

While these changes were occurring, there have been dramatic successes in the infection prevention 
and control field resulting in decreased infections in hospitalized patients.?The modern concept of 

infection prevention and control also includes areas beyond HAIs (e.g., risk to employees, cleaning, 
maintenance and evaluation of the physical environment, health policy, and various other adverse 
events).sin addition, programs must also address risks to the public (e.g., emergency management, 

education of the community, and use of implementation science techniques). 

Infection prevention professionals need to be alert to changing recommendations/requirements and new 
scientific literature and guidelines. They then need to make appropriate modifications to infection 
prevention and control programs. In addition, federal, local, and state requirements must be followed. 
This chapter outlines the specific agencies and organizations that have a major impact on infection 
prevention and control programs and the general issues to consider in the organization and function of 
infection prevention and control programs. 

Organizations Influencing Practice 

AMERICAN HOSPITAL ASSOCIATION 

The AHA's Advisory Committee on Infections within Hospitals published its first edition of Infection 
Control in the Hospitaf\n 1968. The purpose of this manual was to describe the elements of an infection 
prevention and control program that an AHA advisory committee "considers essential to the reduction 
and elimination of the human and economic wastage that results from our failure to prevent those 


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nosocomial infections that are preventable. . . Three editions of the manual were printed, the last 
published in 1979.9The AHA affected infection prevention and control practice through educational 

programs and conferences, journals and other publications, briefings, and consultants. Currently, the 
AHA issues Advisory Reports for healthcare executives, keeps track of legislative and regulatory issues 
regarding HAIs, and maintains its Hospitals in Pursuit of Excellence (HPOE) Web-based platform. The 
HPOE Website disseminates information, shares proven practices, and supports improvement activities. 
The HPOE has also developed Partnership for Patients Hospital Engagement Networks to disseminate 
best practices in 10 focus areas, including HAIs. 

ASSOCIATION FOR PROFESSIONALS IN INFECTION CONTROL AND 
EPIDEMIOLOGY 

The Association for Professionals in Infection Control and Epidemiology (APIC) was established in 1972 
to provide education and science-based information to strengthen and improve the practice of infection 
prevention. APIC's major influences on infection prevention and control activities are its development of 
professional and practice standards, education and training programs, a scientific journal, and 
governmental affairs activities. It established the Certification Board of Infection Control and 
Epidemiology (CBIC) in 1981 to administer an infection prevention and control certification program. 
APIC's research program was established in 1993 and is supervised by the APIC Research Committee. 
The committee coordinates initiatives focused on practical solutions, grounded in science, and that can 
be implemented across the spectrum of healthcare settings.s 

APIC has partnered with other professional organizations to produce two consensus documents outlining 
infrastructure requirements for infection prevention and control programs in hospitals and nonhospital 
settings and a document defining practice and professional standards for the field .101112 A competency 

model has also been developed for professionals to guide their acquisition of knowledge and skills over 
their career .13 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

In the 1960s, the Centers for Disease Control and Prevention (CDC) began recommending that hospitals 
conduct surveillance for the occurrence of healthcare-associated infections (HAIs; previously referred to 
as nosocomial infections). The CDC started training programs in infection surveillance in the early 
1970s. The programs stressed surveillance for infections, developing and implementing policies for 
prevention of infections, and reducing wasteful activities (e.g., environmental culturing). Because of 
increased training opportunities available in the United States, the CDC discontinued these programs in 
1983. 

The Division of Healthcare Quality Promotion (DHQP) of the National Center for Emerging and Zoonotic 
Infectious Diseases is the CDC's focus for information, surveillance, investigation, prevention, and control 
of HAIs. The mission of DHQP is to protect patients, protect healthcare personnel, and promote safety, 
quality, and value in both national and international healthcare delivery systems. 

In January 1970, the CDC began the National Nosocomial Infections Surveillance (NNIS) system. One 
purpose of this program was to monitor trends in HAI rates, pathogens, and antibiotic susceptibility 
patterns in the United States. The CDC transitioned NNIS to a Web-based knowledge system—the 
National Healthcare Safety Network (NHSN)—in 2005. 


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National surveillance of HAIs is coordinated and analyzed by NHSN; the program publishes HAI rate 
data. The NHSN data are intended for benchmarking and can be used by institutions in performance- 
improvement activities .14 

State and federal requirements to report data to NHSN, creating a national database used by payers 
and various states, have led to changes in HAI reporting. These changes include a focus to change, 
improve, and validate surveillance definitions. Reliability of these data in an era of increasing public 
scrutiny is particularly important.is CDC has developed a method, known as the Targeted Assessment 

for Prevention (TAP) strategy , to assist facilities in using their own NHSN data to generate reports that 
help target infection prevention efforts to areas of greatest need. 

In 1974, the CDC initiated a study to determine the efficacy of infection prevention and control activities 
in reducing the risks of HAIs in hospitals: the Study on the Efficacy of Nosocomial Infection Control 
(SENIC) project. The SENIC project defined an infection surveillance and control program as one 
containing three main elements: 

1. Epidemiological surveillance for the occurrence of infections in patients within the hospital 

2. Formulation of policies and procedures to control infections based on data generated by 
surveillance and other sources 

3. Personnel specially trained in hospital epidemiology to collect the surveillance data and coordinate 
intervention activities. 

The SENIC project compared HAI rates that occurred in 1970 and 1976 in a stratified random sample of 
U.S. hospitals.leThe project found that compared to hospitals that had no program activities, hospitals 

that established infection surveillance and control programs reduced their HAI rates by approximately 32 
pereent .17 

The DHQP began an HAI guidelines and recommendation process in 1981. Several documents were 
developed for specific infection prevention and control practices. This process was discontinued in the 
mid-1980s. 

The Healthcare Infection Control Practices Advisory Committee (HICPAC) was established in 1991 to 
provide advice and guidance to the CDC and others regarding the practice of infection prevention and 
control, and strategies for surveillance, prevention, and control of HAIs and antimicrobial resistance. The 
committee influences infection prevention and control programs through its periodic updating of 
guidelines and other policy statements. These guidelines are developed in partnership with various 
affiliated professional organizations. 

CENTERS FOR MEDICARE & MEDICAID SERVICES 

As part of the Centers for Medicare & Medicaid Services (CMS) required conditions for certification and 
participation in Medicare and Medicaid programs, hospitals must comply with federal standards that 
include specific requirements for an active infection prevention and control program.isA program to 

investigate, control, and prevent infections in long-term care facilities accepting Medicare and Medicaid 
patients is also mandated by CMS.19 

In addition, Conditions of Participation (CoP) apply to other healthcare organizations, including 
ambulatory surgery centers, home health agencies, hospices, some providers of outpatient services, and 


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psychiatric hospitals.20 

The CoP related to hospital infection prevention was updated in 2013.isThe standards include 

requirements to maintain a sanitary environment, designate an infection control officer, and develop, 
implement, and maintain an active infection prevention and control program. 

CMS also updated its Medicare hospital inpatient prospective payment system in 2008. It no longer 
reimburses hospitals for certain hospital-acquired conditions (HAC) if it is high-cost, high-volume; not 
present on admission; would be assigned a higher payment because of the HAC; and could reasonably 
have been prevented through application of evidence-based guidelines. 2 iThese efforts are designed to 

increase health, improve care, and lower costs. There are concerns regarding use of administrative data 
versus standardized surveillance definitions as part of this process. 22 See Chapter 4, Accrediting and 

Regulatory Agencies, for more information on CMS requirements. 

CERTIFICATION BOARD OF INFECTION CONTROL AND EPIDEMIOLOGY 

The CBIC is a multidisciplinary board that provides direction for and administers the certification process 
for professionals in infection control and applied epidemiology. CBIC is independent and separate from 
any other infection prevention-related organization or association. The mission of CBIC is to protect the 
public through the development, administration, and promotion of an accredited certification in infection 
prevention and control. 

FOOD AND DRUG ADMINISTRATION 

The Food and Drug Administration (FDA) is responsible for implementing, monitoring, and enforcing 
standards for the safety, efficacy, and labeling of all drugs and biologicals for human use. Of particular 
interest to the infection prevention team are the FDA's activities related to food, blood, medical devices 
(especially single-use devices), and antimicrobial products and chemical germicides used with medical 
devices.iThe Environmental Protection Agency also is involved in testing and use of hospital germicide 

products. 

HEALTH AND HUMAN SERVICES 

The Department of Health and Human Services (HHS) is the principal agency for protecting the health 
of all Americans and providing essential human services. In 2009 the agency increased its focus on 
HAIs with the release of Health-Care-Associated Infections in Hospitals: Leadership Needed from HHS to 
Prioritize Prevention Practices and Improve Data on These lnfections.23lhe HHS has identified the 

reduction of HAIs as an Agency Priority Goal through its National Action Plan to Prevent Health Care- 
Associated Infections: Road Map to Elimination .2 

INSTITUTE FOR HEALTHCARE IMPROVEMENT 

The Institute for Healthcare Improvement (IHI) is an independent not-for-profit organization helping to 
lead the improvement of healthcare throughout the world. IHI works to accelerate improvement by 
building the will for change, cultivating concepts for improving patient care, and helping healthcare 
systems put those ideas into action. 

IHI's 5 Million Lives Campaign was a voluntary initiative to protect patients from 5 million incidents of 
medical harm over 2 years (December 2006 to December 2008). It included prevention of HAIs .24 


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IHI has targeted the identification and subsequent spread of best practices and established a focus on 
innovation regarding HAI reduction. Their current framework focuses on optimizing health system 
performance by centering on the health of a population, the experience of care for individuals within that 
population, and the per capita cost of providing that care. 

THE JOINT COMMISSION 

The Joint Commission (TJC) started publishing minimal infection prevention and control standards for 
hospitals in 1953. In 1976, infection prevention and control programs became a specific requirement for 
accreditation by the TJC.iTJC's standards for infection prevention are used by many institutions, 

including hospitals, long-term care facilities, behavioral health facilities, and home health agencies, to 
establish a framework for an infection prevention and control program. 

These standards have undergone many revisions over the years. In general, the standards state that 
the goal of the surveillance, prevention, and control of infection function is for the healthcare 
organization to identify and reduce the risks of infections in patients and HCP. There must be a 
functioning program, coordinating all activities related to the surveillance, prevention, and control of 
infections. The program should be doing the right things, doing these things well, be supported, and be 
focused toward improvement of processes and outcomes. 2 sSee Chapter 4. Accrediting and 

Regulatory Agencies , for more information on TJC standards. 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 

The National Institute for Occupational Safety and Health (NIOSH) was established in 1970 and became 
part of the CDC in 1973. It is responsible for conducting laboratory and epidemiological research on 
occupational hazards.aeDecisions regarding types of devices used for employee protection (e.g., 

respirators, sharps containers) are part of NIOSH's mandate. 

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION 

The Occupational Safety and Health Administration (OSHA) began its infection prevention and control 
activities in 1987 with the draft publication of bloodborne pathogens rules. These rules were finalized in 
1991.27ln 2001, a revision to the bloodborne pathogens rules was published to clarify issues related to 

sharps safety. 2 sOSHA may enforce other infection prevention issues (e.g., tuberculosis) under the 

General Duty Clause of the Occupational Safety and Health Act. OSHA standards focus on determining 
employees' health risks as the result of exposure to communicable diseases. 

SOCIETY FOR HEALTHCARE EPIDEMIOLOGY OF AMERICA (SHEA) 

The Society for Healthcare Epidemiology of America (SHEA) was founded in 1980 to foster the 
development and application of the science of healthcare epidemiology. 29 SHEA's mission is to prevent 

and control HAIs and advance the field of healthcare epidemiology. 

The organization provides educational programs, develops position papers, and produces a scientific 
journal. SHEA was a partner in the development of two consensus documents outlining infrastructure 
requirements for infection prevention and control programs. 10,11 


Overall Structure and Function 


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Infrastructure documents outline the three principal goals for infection prevention and control programs: 

10,11 

• Protect the patient. 

• Protect HCP, visitors, and others in the healthcare environment. 

• Accomplish the previous two goals in a cost-effective manner whenever possible. 

Each institution is unique, and its specific needs must be considered when developing or reorganizing 
an infection prevention and control program. Factors include size, case mix, and types of care provided. 
The principal functions are generally similar, however, and include the following: 

1. To obtain and manage critical data and information, including surveillance for infections 

2. To develop and recommend policies and procedures 

3. To intervene directly to prevent infections and interrupt the transmission of infectious diseases 

4. To educate and train HCP, patients, and nonmedical caregivers 

Because of differing needs, there may be various groups, individuals, and functions within the 
organization that are responsible for the infection prevention and control program. The following sections 
outline various persons and activities essential to an infection prevention and control program. 

INFECTION PREVENTION TEAM 

Often the core of the infection prevention and control program is the infection preventionist (IP), chair of 
the infection prevention committee, and the healthcare epidemiologist. An individual responsible for 
occupational health or administration also may be a part of this team. The team is responsible for 
carrying out all aspects of the infection prevention and control program. There should be one person, 
however, who is designated as having responsibility for the program.io,nTeam members must be 

qualified and guided by sound principles and current information. It should set goals, collect and analyze 
data, and select interventions. 

A facility may have an infection prevention committee (IPC) that functions as the central decision-making 
and policy-making body for infection prevention. The IPC chair reports to the medical staff and/or 
administration. The IPC acts as the advocate for prevention and control of infections in the facility, 
formulates and monitors patient care policies, educates staff, and provides political support that 
empowers the team. 30 31 

The IPC must be multidisciplinary, composed of representatives from appropriate departments; examples 
include nursing, administration, engineering, pharmacy, building management. It should meet regularly, 
usually monthly or quarterly. Representation typically includes members of administration and clinical 
and ancillary staff. Because infection prevention issues and measures often cross departmental lines, an 
IPC that is multidisciplinary is crucial. 

The IPC often refines and ratifies the ideas of the infection prevention team. Its members disseminate 
the information discussed in the meeting. 

An IPC is not required by TJC; however, some states do require an IPC (also called an infection control 
committee). Institutions may support a committee structure for the reasons outlined earlier. If a 
committee is not used, the infection prevention team needs to develop other mechanisms (e.g., use of 
quality improvement [Ql] models) to obtain multidisciplinary support for changes and actions. Ql models 
use a collaborative approach, including use of multidisciplinary teams. These teams meet regularly and 


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are responsible for planning, policy development, interventions, and decision making. The team leader 
may be the infection prevention professional. 

Dissemination of infection prevention information is a crucial component of an infection prevention and 
control program. Surveillance data and policy decisions should be communicated throughout the 
organization. This communication may be accomplished through routine written and/or verbal reports to 
clinicians, committees, and/or department heads and through various electronic methods. It is important 
to provide appropriate information to medical staff and administration as well as front-line HCP. 

INFECTION PREVENTION PROFESSIONALS 

There are two key infection prevention professionals: the IP and the healthcare epidemiologist. The IP 
predominately has a background in nursing, medical technology, microbiology, or public health. 32 

Additional titles used by IPs may include infection control nurse, infection control coordinator, nurse 
epidemiologist, infection control officer, and infection control practitioner. The IP's role involves the daily 
collaborative efforts within all facets of healthcare. The IP typically functions as a consultant, educator, 
role model, researcher, and change agent. Infection prevention and control responsibilities include 
education, consultation, surveillance, implementation science, patient safety, and quality improvement .12 

The healthcare epidemiologist may be the chair of the IPC or may occupy a separate position as either 
a technical advisor or member of the committee. This person is often a physician with special training in 
healthcare epidemiology and infection prevention. In the United States, the position is usually filled by 
an infectious diseases physician who works closely with the medical staff. 

Depending on the institution, infection prevention professionals may report to administration, nursing or 
medical services, or quality improvement departments; other reporting relationships also exist. In some 
institutions, the infection prevention and control program is integrated with other departments (e.g., risk 
management, utilization/case management, patient safety, or quality improvement). 

The role of infection prevention professionals includes responsibilities such as the following:io,n,i2,3i 

1. Collection and analysis of infection data 

2. Evaluation of products and procedures 

3. Development and review of policies and procedures 

4. Consultation on infection risk assessment, prevention, and control strategies (includes activities 
related to occupational health, construction, and emergency management) 

5. Education efforts directed at interventions to reduce infection risks 

6 . Education of patients and families 

7. Implementation of changes mandated by regulatory, accrediting, and licensing agencies (includes 
reporting communicable diseases to health departments) 

8. Application of epidemiological principles, including activities directed at improving patient outcomes 
using implementation seienee33 34 

9. Antimicrobial management 

10. Participation in research projects 

11. Provision of high-quality services in a cost-efficient manner 

Some infection prevention professionals work less than full-time on infection prevention. They also may 
be involved in such areas as occupational health, quality improvement, patient safety, and risk 
management. In nonacute care facilities, infection prevention professionals typically have multiple roles 


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to fill and usually have a designated number of hours per week to devote to infection prevention 
activities.35 

An infection prevention professional's time is split among data management, policy and procedure 
development, education, occupational health, quality improvement, program development, consulting, 
and investigating potential outbreaks. Infection prevention professionals should be involved in 
implementation science activities and some may take part in Institutional Review Board (IRB)-approved 
research activities.i 2 Task and job analyses have been performed to specify what the infection prevention 

professional's day-to-day work may entail.3eThe development and availability of electronic data mining 

systems have impacted the infection prevention professional's day-to-day priorities, an area which is still 
under evaluation. The infection prevention professional may also be involved in investigations related to 
adverse outcomes other than infections. 37 

Successful infection prevention professionals improve their leadership strategies and pursue 
opportunities for self-development.eCertification for infection prevention professionals is available through 

CBIC. Practice and professional standards are available for various practice settings and professional 
backgrounds and include key indicators to be used in evaluating both the competency of the individual 
and their practice. The key indicators represent multiple skills considered necessary to meet the 
demands of the evolving healthcare environment.i 2 ln addition, competency models are available for 

professionals to use for successful practice. 13 ,38 

Many training courses exist for infection prevention professionals. Local and national APIC organizations, 
SHEA, state organizations, academic institutions, and private firms offer training courses. Courses are 
available for both beginning and experienced individuals. 

STAFFING 

In 1969 the CDC recommended one full-time IP for every 250 occupied beds on the basis of pilot 
studies in eight community hospitals in which different staffing levels were evaluated.39The SENIC 

project strongly supported the 250-bed recommendation .16 

Because the CDC recommendation is more than 40 years old, these staffing recommendations are 
outdated. This is especially true because there have been dramatically increased demands on the IP's 
time for surveillance, education, quality improvement, patient safety, and consultation in addition to many 
changes in healthcare. Changes in healthcare delivery have also expanded the range of infection 
prevention activities. These programs require sufficient resources to be effective and maintain program 
responsibilities. 4 , 40 ,4iln most acute care hospitals, the IP's scope of work is much greater than that 

evaluated in the CDC recommendation. 

A 2004 Health Canada model projected three full-time IPs for every 500 beds in acute care hospitals .42 

A group in the Netherlands estimated that one full-time IP was needed per 178 hospital beds or one per 
5,000 admissions. The Dutch group also estimated one infectious disease physician was needed for 
every 25,000 admissions .43 

One work group in California categorized the major functions of the infection prevention and control 
program created a method that uses workload units to develop staffing requirements. 44 A Belgian 


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Department of Health working group adopted a point system for staffing. The number of infection 
prevention professionals required is based on the number of points obtained by multiplying the number 
of beds of each patient-care unit by a factor that is specific for the patient population treated in the unit. 

45 

APIC initiated a Delphi project on staffing that was published in 2002.46lt noted that staffing 

recommendations must consider the number of occupied beds, scope of the program, complexity of the 
healthcare facility, characteristics of the patient population, and unique needs of the facility. This study 
recommends a ratio of 0.8 to 1.0 IP for every 100 occupied acute care beds. 

Long-term care facility resources have also been evaluated.47The Health Canada study estimated the 
need for one full-time IP per 150 to 250 beds.42The Delphi project assessed the need for 0.8 IPs for a 
facility with 100 beds, increasing to three for a 500-bed facility.46A Dutch group estimated a need of 500 
hours per 100 residents per year.48 

CMS does not specify either the number of infection prevention professionals to be designated or the 
number of hours that must be devoted to infection prevention and control programs. However, resources 
must be adequate to accomplish the tasks required for the program. It recommends using studies and 
recommendations on resource allocation published by APIC and SHEA to make staffing decisions.is 


Documenting Impact of Healthcare Associated Infections on 
Outcomes and Costs 

The SENIC project found that one third of HAIs could be prevented by effective infection prevention and 
control programs that included surveillance and practice activities. The project also noted that prevention 
of approximately 6 percent of HAIs offset the cost of a program in a 250-bed hospital.ie 

Part of a program's effectiveness is a reflection of the influence of infection prevention professionals. 
They must be visible, provide a resource for staff, and use their scientific expertise when making 
specific recommendations. Effectiveness also depends on commitment to infection prevention by 
administration.49 

It is important to outline the cost-benefit of an infection prevention and control program.soDemonstrating 

value is important for healthcare facilities that need to make economic decisions regarding support for 
infection prevention and control programs.siTargeted surveillance should be tied to specific interventions 

to decrease HAIs. Appropriate interventions to decrease infections will then result in documentation of 
cost savings.7 

Economic evaluations can be used to compare costs with outcomes.52Cost-effectiveness and cost-benefit 

are examples of decision analysis studies. Effecf/Venessrefers to the outcome of care. It can be 
expressed as the number of cases of disease prevented, the number of lives saved, or the number of 
life-years saved. Cost-benefitana\ys\s looks at outcomes in terms of cost. Benefits other than direct 
financial costs also are important in evaluating the impact of infection prevention activities. These 


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include decreasing malpractice claims, protecting employees from injury, assisting in patient safety 
efforts, and enhancing the organization's image .53 

Various methods can be used to estimate how much HAIs cost an institution. The cost of the infection 
prevention program itself consists of salaries, employee benefits, education, and commodity expenses. 
Cost-benefit estimates also can be developed for mortality and morbidity in patients. A crude estimate of 
cost can be obtained by multiplying the estimated numbers of HAIs at various sites by the site-specific 
cost weights (cost per infection) and adjusted for time. Other methods use actual cost weights or costs 
determined through prospective, randomized studies. Prevalence surveys also can be used to assess 
the costs of HAIs .54 


Influencing Practice 

CHARACTERISTICS OF THE ORGANIZATION 

The ability of the infection prevention and control program to influence practices that affect safe patient 
care depends on certain characteristics of the patient population, patients' risk of infection, and 
characteristics of the organization and personnel. These characteristics include number of beds, 
professional school affiliation, geography, volume of patient encounters, patient population served, 
clinical focus, number of employees, and administrative philosophy. It is important to understand these 
characteristics when developing a program to optimally meet the infection prevention needs of the 
organization and the patients it serves. 

Written infection prevention policies are often developed that relate to staff and patient-care practices, 
construction/renovation, emergency management, occupational health, and sterilization/disinfection. 
General policies are applicable to staff in the whole facility. These policies may form the basis of an 
infection prevention manual. Specific policies may also be developed for each unit or area. These 
policies must be supported scientifically and address the infection prevention needs for the institution. 

However, providers of direct patient care must implement these policies consistently to benefit patients 
and protect staff. Infection prevention professionals usually attempt to affect patient care outcomes by 
influencing other healthcare personnel and their practices. Teaching personnel to increase their 
knowledge and skills of appropriate infection prevention practices is one method to influence quality 
patient care and protect employees. Education of staff is crucial to the success of any infection 
prevention and control program. 

The infection prevention and control program thus influences practice through direct actions (e.g., review 
and evaluation of products, policy and procedure review and development, and observations). In 
addition, training and education of staff can assist in skill development and increase employees' 
knowledge base to affect practice. 

PATIENT SAFETY 

Infection prevention personnel play a crucial role in preventing infections and other adverse events. 55 

Because of their expertise in epidemiological methods, IPs can support infection prevention, quality 
improvement, patient safety, and adverse health-event reduction programs. Infection prevention 
professionals can use basic healthcare epidemiology (e.g., surveillance, outbreak investigation, and 
special studies), implementation science, and other quality improvement tools (e.g., root cause analysis) 


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to improve patient outcomes. Implementation science can be useful in transitioning evidence-based 
practices into routine work .34 

ADMINISTRATIVE SUPPORT 

It is important that the administrative leaders of the organization approve and support its infection 
prevention activities. Infection prevention professionals should schedule regular meetings with the 
administrator to whom they are responsible. This practice helps to maintain liaison between the program 
and administration and increase awareness of the institution's leaders of infection prevention and control 
program activities. There should also be routine reports presented to senior leaders. 

Quality of an Infection Prevention and Control Program 

The interdisciplinary infection prevention team determines goals and objectives for the infection 
prevention and control program by performing an annual risk assessment.ssThese should be based on 

the institution's strategic goals and institutional data and findings from the previous year's activities. 
Identification of high volume, high risk, and problem prone activities is an important component of the 
risk assessment. Infection prevention resources and data systems needs should be evaluated in the 
context of these goals and objectives. The risk assessment can assist in setting priorities and obtaining 
support from key stakeholders. 

Set priorities to help focus on appropriate allocation of infection prevention and control program 
resources. Realistic strategies for surveillance and intervention should be developed. Steps to use in this 
process include the followings 

1. Establishing a reliable, focused surveillance program based on the annual risk assessment 

2. Streamlining data management activities 

3. Analyzing HAI rates 

4. Aiming for zero HAI rates 

5. Educating staff regarding prevention strategies 

6 . Identifying opportunities for performance improvement 

7. Taking a leadership role on performance improvement teams 

8 . Developing and implementing action plans that outline the steps needed to accomplish each 
objective 

9. Evaluating the success of action plans in accomplishing the goals and objectives of the infection 
prevention plan 

The quality of the infection prevention and control program should be assessed routinely by evaluating 
customer satisfaction, appropriateness, efficacy, timeliness, availability, effectiveness, and efficiency. 

An annual evaluation of the infection prevention and control program is important to outline 
achievements and activities of the program and describe support requirements. The value of the 
infection prevention and control program to the organization should be emphasized, along with patient 
outcomes and cost savings. This evaluation report should be widely disseminated to leaders throughout 
the organization, in particular to the chief executive officer, chief medical and nursing executives, and 
board members. 

An additional method to explain the importance of the program to others is through a mission statement, 
a description of the vision for the program, and an outline of core values. 

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International Perspective 

Infection prevention and control programs worldwide are organized around local guidelines and 
regulations to optimize quality healthcare and are influenced by various payer modelsjssthere are many 

different models. The International Federation of Infection Control produces a handbook that includes 
information on infection prevention and control programs.sgThe World Health Organization recommends 

an appointed technical team of trained nursing and medical professionals who are responsible for 
organizing, implementing, and monitoring practices.so si 

Programs in most countries are coordinated through an infection prevention team, typically a physician 
(infectious disease physician) and an infection control nurse. 62 The infection control doctor could be a 

medical microbiologist, an epidemiologist, or an infectious diseases physician. An infection control nurse 
is typically a registered nurse with an academic education (perhaps with a qualification, such as 
specialized training) and practical training that enables him or her to act as a specialist advisor in all 
aspects relating to infection prevention and control. 

The team coordinates the planning, implementation, and evaluation of the program. It is responsible for 
the day-to-day running of the program. Many programs use infection control link nurses to develop 
educational programs and provide operational support. They help identify problems, implement solutions, 
and maintain communications with the team. 

Supplemental Resources 

Friedman C, Petersen KH, eds. Organizing for infection prevention, surveillance, and control. In: 

Infection Control in Ambulatory Care. Sudbury, MA: Jones & Bartlett, 2004:189-191. 

Larson E. A retrospective on infection control. Part 1: Nineteenth century—Consumed by fire. Am J 
Infect Control 1997;25:236-241. 

Scheckler WE. Hospital epidemiology and infection control in small hospitals. In: Mayhall CG, ed. 

Hospital Epidemiology and Infection Control, 3rd ed. Philadelphia: Lippincott Williams & Wilkins, 
2004:1849-1853. 

Selwyn S. Hospital infection: The first 2500 years. J Hosp /nfecf1991;18 (suppl A):5-64. 

Web-Based Resources 

Association for Professionals in Infection Control and Epidemiology (APIC). Available at: 
http://www.apic.orq . 

Centers for Disease Control and Prevention (CDC). Available at: http://www.cdc.aov . 

Certification Board of Infection Control and Epidemiology (CBIC). Available at: http://www.cbic.org . 
Institute for Healthcare Improvement (IHI). Available at: http://www.ihi.ora/ihi . 

The CDC Hospital Infection Control Practices Advisory Committee (HICPAC). Available at: 

http://www.cdc.aov/hicpac/7s cid=dhqp Oil . 


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National Healthcare Safety Network (NHSN). Available at: http://www.cdc.aov/hicpac/? 
s cid=dhqp Oil . 

Public Health Ontario. Best Practices for Infection Prevention and Control Programs in Ontario, May 
2012. Available at: 

http://www.publichealthontario.ca/en/eRePositorv/BP IPAC Ontario HCSettinas 2012.pdf . 

Society for Healthcare Epidemiology of America (SHEA). Available at: 

http://www.publichealthontario.ca/en/eRePositorv/BP IPAC Ontario HCSettinas 2012.pdf . 

The Joint Commission (TJC). Available at: 

http://www.Publichealthontario.ca/en/eRePositorv/BP IPAC Ontario HCSettinas 2012.pdf . 

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APIC 

XnVT OF INFECTION CONTROL 
1 tyy I AND EPIDEMIOLOGY 


Competency and Certification of Infection 
Prevention ists 


Author(s): Ruth Carrico, PhD, RN, FSHEA, CIC 
Associate Professor 

Division of Infectious Diseases 
School of Medicine 
University of Louisville 
Louisville, KY 

Linda Goss, BS, MSN, APRN-NP, BC, CIC, COHN-S 
Infection Preventionist 

Norton Brownsboro Hospital 
Infectious Disease Nurse Practitioner 
Norton Infectious Disease Specialists 
Louisville, KY 

Kathryn N. Suh, MD, FRCPC, CIC 

Associate Director, Infection Prevention and Control 

The Ottawa Hospital, Civic Campus 
Ottawa, Ontario, Canada 

Published: November 26, 2014 


Abstract 

Professional development of the infection preventionist remains an essential component of practice. 
Increased focus on patient safety, as well as more intensive public reporting and regulatory 
requirements, places increasing emphasis on developing and maintaining the skills of the infection 
preventionist. Achieving competence can be accomplished by addressing the domains of the Association 
for Professionals in Infection Control and Epidemiology competency mode! and applying them to the 
infection preventionist's individual practice. The infection preventionist can begin the process by 
evaluating his or her current practice and using the tool to help determine areas for further 

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improvement, as well as career goals. A focus of the infection preventionist's development should 
include demonstration of competence through success in the certification examination, with recognition 
by earning the designation of being Certified in Infection Control. 

Key Concepts 

• Professional development is essential to keeping the infection preventionist up-to-date with the latest 
knowledge, skills, and strategies for preventing infections. 

• Competence implies an expert level of knowledge and skill that is transferrable to the practice of 
infection prevention and control. 

• Core competencies are necessary to ensure that the infection preventionist has a set of basic skills to 
integrate into any practice setting; these are defined by the Certification Board of Infection Control 
and Epidemiology, Inc. 

• Certification is the pinnacle of practice and serves as one measure of validation of the infection 
preventionist's expertise. 

• Advanced education is a mechanism to assist infection preventionists as they progress in their 
desired career paths. 

Background 

Competence of the infection preventionist (IP) has traditionally been a mixture of subjective and 
objective interpretation, founded on an individual IP's position description. Competence is often assessed 
by comparison of the IP's current workload to the listed tasks on his or her performance evaluation. 
Recognized professional standards for the IPimay or may not be integrated into such performance 

evaluations; if not, then this method of assessment lacks the objective criteria necessary to properly 
evaluate the IP with respect to his or her ability to apply skills and knowledge appropriately. The wide 
variability of assigned tasks associated with an IP's job can be daunting. Core competencies play a 
crucial role in guiding the IP to competence and to the next level of his or her career. 

This chapter provides an introduction to the newly released Association for Professionals in Infection 
Control and Epidemiology (APIC) competency model, defines the various domains within the model and 
addresses the career levels of the IP, and discusses the significance of certification as a measure of 
practice validation. 

Basic Principles 

What is competence? Competence in infection prevention and control, as in other specialty areas in 
healthcare, implies the ability to apply learned knowledge in a variety of different clinical settings and 
situations. Competence has been defined as the "essential knowledge, behaviors, and skills that an 
individual should possess and demonstrate to practice in a specific discipline." 2 Simply stated, it is the 

ability to put knowledge into action. Both theoretical knowledge and clinical experience are requisites for 
the competent IP, who must be able to readily adapt content and practical knowledge while making 
critical decisions on a regular basis. 


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While competence can be achieved through education and clinical experience, only certification of the IP 
formally recognizes competence and indicates that an individual has met the standards that are 
essential for the practice of infection prevention and control. Demonstration of competence is crucial for 
IPs as it serves as a tangible and public demonstration of professional and practice emphasis on 
protecting the safety of patients, healthcare personnel, and communities. 

Certification is not the same as licensure, nor is it related to continuing education. It is, in fact, a step 
beyond both. Continuing education presents opportunities to acquire general or focused knowledge 
through lecture, discussion, or interactive methods. It may accompany some level of knowledge testing 
through a pre- and post-education assessment or demonstration, and plays a valuable role in 
introducing knowledge and areas of study. It does not, however, require specific knowledge or skill 
demonstrations that can be consistently measured or applied. Licensure indicates that an individual has 
met the minimum requirements to practice, whereas certification signifies that expertise has been 
attained in a specific field and that the certified individual has mastered the skills and knowledge 
required to practice competently in that field. In contrast to licensure, which is regulated by 
governmental organizations (e.g., state or provincial nursing or medical boards), certification is overseen 
by nongovernmental certifying bodies. Certifying bodies should, in turn, be accredited and meet 
accepted standards for the certification process. Certification provides the opportunity for the individual 
to demonstrate what has been learned through practice and continuing education by using standardized, 
validated methods to assess competence. 

The APIC Competency Model 

The APIC competency model, initially introduced as a concept, identifies four separate but 
complementary and essential domains to describe areas of concentration for mastery by the IP.3These 

four domains encompass technology, performance management and implementation science, leadership, 
and infection prevention and control. The model also serves as a tool that enables the IP to assess his 
or her individual knowledge and skill and direct further professional development, and may be useful to 
identify future career paths. Central to the model is the safety of the patient; concentric layers reflect 
the advancing stages of the IP's professional career (career states), with the four domains intersecting 
every stage of the IP's career (Figure 2-1). 

CAREER STATES 

The ever-changing landscape of healthcare requires the IP to develop and remain competent in the 
field. APIC has identified three levels of practice and outlined the competencies required in each level. 
There is no specific time frame identified for a person to advance through each level. Listed here, and 
shown in Figure 2-1, are some of the criteria needed to demonstrate competence in each level. 

Early (Novice) 

• Is completing or has obtained a baccalaureate degree 

• Seeks information and develops fundamental infection prevention and control skills 

• Performs surveillance and creates reports based on data 

• Is learning the basics of epidemiology 

• Develops policies 


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• Is preparing to become certified in infection prevention (Certified in Infection Control [CIC®]) through 
the Certification Board of Infection Control (CBIC) 

Middle (Proficient) 

• Meets all of the requirements for the novice IP 

• Has a baccalaureate degree 

• Has achieved CIC® 

• Has a diverse skill set 

• Is a critical thinker 

• Is considering work toward an advanced degree 

• Mentors new IPs and those preparing for the certification exam 

• Functions successfully in team-based activities 

• Demonstrates competence as an IP and patient safety advocate 

• Is active in a local chapter of a professional association or society 

• Holds leadership positions at chapter level 

Advanced (Expert) 

• Demonstrates competence at both the novice and proficient level 

• Holds an advanced degree 

• Demonstrates expertise in leadership, management, education, consultation, advanced analysis, and 
strategic planning 

• Maintains and supports certification in infection prevention 

• Mentors new IPs and those interested in becoming experts in the field 

• Is a recognized leader and champion of patient safety and infection prevention 

• Is involved in professional associations or societies at the chapter and national levels 

• Presents educational programs at the chapter and national levels 
Figure 2-1. 


THE DOMAINS OF THE APIC COMPETENCY MODEL 


View Image SI 


Leadership and Program Management 

IPs' roles vary and may include specific leadership responsibilities. However, regardless of their official 
titles, IPs are considered subject matter experts and leaders in the field. The IP's leadership ability 
relies on the ability to influence others, using skills that facilitate prevention activities. Collaboration with 
leaders, other team members, and colleagues positions the IP at the forefront of the specific task or 
project, while placing emphasis on incorporating infection prevention in every department. Collaborative 
efforts of the IP may be manifested in the form of followership. The IP may not be leading the project or 
change effort, but the ability to demonstrate followership can be strategic and interdependent with 
leadership.4 


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2. Compatarcy aril Cvillcakn of Madkm nnalukb | Omrv M of Irfadkai Prwwflm | TaUa d CcrimiM | AP1C 

The IP at any level must be able to manage the bally 
surveillance and regulatory workload and at the same 
time be prepared to address competing priorities that 
may arise. The IP does not have to be officially 
designated as the program manager to develop, 
maintain, and articulate die goals and objectives of 
the department. Each IP collectively contributes to the 
outcomes of the prevention efforts. Leadership builds 
effective programs and Is evidenced by the ability to 
be flexible and realign goals when necessary. The IP 
Includes In his or her arsenal critical-thinking skills to 
address complex situations and Issues. One definition 
of critical thinking Is "the Intellectually disciplined 
process of actively and skillfully conceptualizing, 
applying, analyzing, synthesizing, and/or evaluating 
Information gathered from, or generated by, 
observation, experience, reflection, reasoning, or 
communication, to guide belief or acdon."s 

Competence In leadership may be most evident In the 
communication skills of the IP. The articulation of 
critical Information must be timely, accurate, and 
address the various learning needs of the audience. 
Messaging of Infection prevention Information can 
promote or Inhibit, depending on how It Is delivered. 

Infection Prevention and Controi 

Core competencies as defined by CBIC are Identified by conducting periodic practice (Job) analyeessand 

are essential In developing the IP. Infection prevention Is dynamic and continually evolving as emerging 
Infoctloue diseases and naturally occurring events require new methodologies for prevention. 
Surveillance, Including the application of definitions and analysis of data, Is an area In which the IP must 
be knowledgeable. The IP uses surveillance data to Identify trends and Investigate outbreaks. The risk 
assessment, which Identifies patient populations and potential organizationally Inherent concerns that 
contribute to the development of healthcare-associated Infections (HAls), Is a crucial program element. 
Performing a risk assessment adequately Is essential In the development of prevention strategies to 
reduce risk to patients. Risk reduction Includes not only the specific measures to reduce HAI rates, but 
also those related to construction and renovation, as well as the evaluation of new products and 
technologies. 

Additional components of the Infection prevention and control domain Indude antimicrobial stewardship 
(AS), education, and research. AS Is defined as "the coordinated Interventions designed to Improve and 
measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial 
drug regimen, dose, duration of therapy, and route of administration.*7The role of IPs In supporting AS 

programs Is most evident by their role In surveillance for organisms of epidemiologic concern and their 
ability to share findings In a manner that promotes Interprofessional practice and practice change. Tha 
IP supports the learning needs of the facility's employees as well as patients. Orientation and "on-the- 
spot 1 education are a few ways IPs deliver crucial Information and train healthcare personnel In 


APIC Competency Model 
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prevention methods. The availability of the IP as an education resource highlights the significance of the 
role of subject matter expert. Education is often structured around the latest research and IPs should 
employ critical-thinking skills in the interpretation of the latest research; they may even participate in 
research studies if time and resources allow. 

Technology 

HAI surveillance is an essential component of infection prevention practice that requires intensive, 
systematic collection, and analysis of data. As reporting demands increase at the facility, state, and 
national levels, IPs must be able to provide timely and accurate data to key stakeholders. IPs must be 
proficient in the use of surveillance technology and health informatics. Rapid changes in this domain will 
require mastery in the area of information technology (IT). 

IPs are expected to have access to IT hardware and be proficient in the use of software including word 
processing, spreadsheets, and presentation and communications applications. In addition, IPs must also 
have ready access to clinical and administrative data related to patient care, such as electronic medical 
records (EMRs), admission/discharge/transfer (ADT) data and bed assignment information, and 
pharmacy, radiology, and surgery information. Often, IPs must engage IT professionals for assistance in 
extracting information from this myriad electronic resources. IPs must be skilled at communicating their 
needs to IT professionals and must be prepared to assist them in the development of requested 
reports. It is also important to validate automated reports to ensure accuracy and data integrity. In the 
United States, the advent of mandatory public reporting of HAIs and federal pay-for-performance 
initiatives that rely on infection prevention and control data make it crucial that IPs have solid support 
from their IT professionals. 

As surveillance and reporting demands increase, more advanced analytical surveillance support tools 
have become essential. With interfaces from IT, source systems like EMRs, and ADT, pharmacy, 
radiology, and surgery databases, data mining systems can augment an infection prevention and control 
program by automating work that has traditionally been performed manually. Some surveillance 
technology systems can detect clusters and outbreaks, create automated alerts for multidrug-resistant 
organisms, and provide decision support to clinicians. All of these help improve the IP's efficiency by 
automating pieces of the surveillance process and aggregating data from many sources into one 
system. Many surveillance technology system vendors have collaborated with the Centers for Disease 
Control and Prevention (CDC) to support automated or semi-automated transfer of HAI data into 
National Healthcare Safety Network (NHSN) databases. As electronic methods become more 
commonplace and useful, it is incumbent upon IPs to be familiar with this technology. IPs should be able 
to make a business case for obtaining an electronic surveillance system, emphasizing the reallocation of 
their time from data collection and data entry to implementation of prevention strategies and 
interventions at the point of care. IPs must also understand both the strengths and the limitations of 
data mining and surveillance technology systems. 

Relatively few U.S. health systems have a fully functional EMR that includes computerized provider order 
entry and clinical documentation. However, federally funded initiatives under The Health Information 
Technology for Economic and Clinical Health (HITECH) Act, also known as Meaningful Use initiatives, 
have incentivized the adoption of fully functional EMRs.sEMRs and electronic data warehouses can be 

powerful tools for collection and analysis of infection prevention and control data, including device days, 
impact of infections on resource utilization, and effectiveness of infection prevention and control 
interventions. IPs must have a knowledge base in IT systems as well as communication channels and 
relationships with their IT professionals to ensure inclusion in the development of electronic records and 
databases. 


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Performance Improvement and Implementation Science 

Performance improvement and implementation science are complementary. In infection prevention and 
control, the goal of both is to improve quality of care by reducing HAIs through the consistent 
application of evidence-based practice and improved application of best practices at all levels and in all 
healthcare settings. 

Implementation science refers to the process of translating evidence-based practices and research 
findings into practice.9lt is the field of science that seeks to identify methods that facilitate and promote 

the integration of research findings and the evidence into healthcare practice and policy. The Institute of 
Medicine has embraced implementation science as a vital foundation for moving research findings into 
practice.loThe notion of "translational research" looks for means to directly apply science into practice. 

This concept is critical for the IP as it underscores the importance of research and finding answers to 
common, shared, and emerging questions in the field of infection prevention. The IP must have the 
skills to critically review and understand the scientific evidence regarding infection prevention 
interventions, and engage and educate a diverse group of stakeholders (e.g., nurses, radiology 
technicians, respiratory therapists, physicians, environmental services staff, administrators) to 
successfully implement those practices and research findings, and then to measure success and impact. 
n,i 2 lntegral to this process is the identification of facilitators of and development of strategies to 

overcome barriers to implementation, in order to maximize acceptance of, and compliance with, the 
interventions by all relevant stakeholders. Examples of common barriers to implementation include lack 
of access to supplies, workflow and turnaround time constraints, and inadequate space or staffing .11 

Tools such as bundles, checklists, daily rounds sheets, and automated reminders in EMRs help ensure 
that the practice is relevant and applicable to all patients and care providers. Measurable outcomes can 
be process measures and/or outcome measures.i3Process measures refer to the practices of healthcare 

personnel in delivering care, such as compliance with equipment disinfection in between patients, hand 
hygiene, use of personal protective equipment, or adherence to a clinical bundle to prevent infection. 
Outcome measures refer to the results of care provided, such as infection rates, mortality rates, and 
readmission rates. 

Performance improvement involves making changes to an existing practice or process in order to 
improve an associated outcome. An IP may be responsible for identifying specific areas of need and for 
leading performance improvement initiatives relevant to HAIs, developing a project charter, forming a 
team with clearly defined roles, selecting methods, engaging in rigorous measurement, and assuming 
accountability. Plan-do-study-act (PDSA) cycles, Lean Six Sigma, or continuous performance 
improvement (CPI) methods are all accepted methods for performance improvement activities. (See 16 . 
Quality Concepts .) 

The importance of best practices cannot be overstated: Ultimately, patients deserve the finest care 
available. However, it is too often the case that evidence-based practices have not been adequately 
integrated. Implementation science and performance improvement are two essential disciplines that can 
allow IPs to foster a safe, efficient, and effective environment. 

Determining the Core Competencies Required for the 
Certified Infection Preventionist 


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In North America, certification in infection prevention and control is administered by CBIC 
( www.cbic.ora t. which was created by APIC in 1981 to develop and oversee certification for infection 
control professionals. However, CBIC is an autonomously functioning organization with its own volunteer 
board. At present there are almost 6,000 certified (CIC®) IPs, most of whom practice in the United 
States and Canada. The certification process used by CBIC is accredited every 5 years by the National 
Commission for Certifying Agencies ( http://www.credentialinaexcellence.ora/ncca ). whose mission is 
to "help ensure the health, welfare, and safety of the public through the accreditation of a variety of 
certification programs/organizations that assess professional competence." Additional information 
regarding certification excellence and the conceptual basis behind organized certification methods can 
be found on the Institute for Credentialing Excellence website 
( http://www.credentialinaexcellence.org ). 

A job or practice analysis (survey) is conducted every 4 to 5 years to determine the competencies that 
a practicing IP should possess. This interval typically reflects the period over which major changes in 
most IPs' roles would become evident. The survey is distributed to certified IPs worldwide and members 
of partner organizations in North America (APIC and IPAC-Canada, formerly CHICA-Canada) in order to 
assess the knowledge and skills required of practicing IPs, as well as their current roles and 
responsibilities. Individual IPs may have varied roles and responsibilities and may need to employ 
different skill sets within their own workplaces, but the majority of these can be categorized into several 
major domains. A content outline, which identifies the major domains ("core competencies") of skills and 
knowledge required by practicing IPs, is developed based on survey responses. The content outline 
forms the basic framework around which examination questions for both the computer-based test (CBT) 
and self-achievement recertification examination (SARE) are constructed. The 2010 content outline was 
based on a practice analysis conducted in 2009.6 


Benefits and Impact of Certification 

BENEFITS OF CERTIFICATION 

Certification is of particular importance in healthcare-related disciplines given the expanding scope of 
many specialties in an era when the complexity of both patient care and healthcare delivery is 
increasing. For infection prevention and control, there are the additional elements of intensified public 
and government interest in preventable HAIs. 

Certification provides personal benefits to certificants: a sense of accomplishment and self-satisfaction; 
increased recognition, credibility, and confidence; and enhanced personal growth and development. 
Certification increases an individual's sense of empowerment compared with those who are not certified, 
as demonstrated in one study of critical care nurses. Certificants are also more likely to demonstrate a 
lifelong commitment to learning, enhance the profession, and are less likely to leave their current 
positions .14 

THE IMPACT OF CERTIFICATION 

The most important benefits of certification in healthcare specialties are those that are provided to 
patients: improved clinical outcomes among patients who are cared for by certified staff. The association 
between certification and improved clinical outcomes is becoming more evident and has been 
demonstrated in intensive care and medical-surgical units, surgical services, and oncology. 15 , 16,17 

Certified staff may be better able to manage patient symptoms and are more knowledgeable regarding 


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established practice standards and guidelines.lsUnits with higher proportions of certified staff have had 

lower rates of falls and of urinary tract and bloodstream infections among critically ill patients.i6,i7ln one 

study, 30-day inpatient mortality was inversely related to the proportion of certified staff within healthcare 
facilities. is 

What evidence is there that certification in infection prevention and control similarly improves patient 
outcomes? To date, three published studies support the value of certification. Pogorzelska et al. 
highlighted the importance of certification among IPs and its significant impact on infection rates 
involving multidrug-resistant organisms, notably methicillin-resistant Staphylococcus aureus( MRSA) 
bloodstream infections.i9ln 2013, Saint and colleagues sought to determine perceived strength of 

evidence of common practices aimed at preventing device- and procedure-associated infections. 2 oHis 

team surveyed hospital IPs looking at practices implemented to prevent those types of infections, and 
results were stratified by certification status of IPs. Certified IPs were more likely to perceive the 
evidence as strong for certain preventive activities than were their noncertified colleagues. The 
implication is that certification may lead to greater use of evidence-based practice. Finally, Carrico and 
colleagues surveyed practicing IPs across multiple settings regarding immunization practices, vaccine 
handling, and program management. 2 iTheir findings indicated that programs managed by certified IPs 

were more likely to adhere to recognized best practices when compared with their noncertified 
colleagues. These three studies serve to recognize the value of IP certification and are the first to 
demonstrate that certification in infection control can positively impact practice and outcomes. 

The Certification Examination 

DEVELOPING AND SCORING THE CERTIFICATION EXAMINATION 

Both the CBT and the SARE are computer-based examinations that consist of 150 multiple-choice 
questions. The 3-hour, proctored CBT is intended for the first time certifier and is geared toward the IP 
with 2 years' experience but is also available to those needing to recertify. The "open book" SARE, 
which may be completed while researching answers to questions, is intended to challenge the test taker 
to demonstrate continued mastery of infection prevention and control; it is only available for 
recertification and can be completed in multiple sessions on an ongoing basis over one calendar year. 

As mentioned previously, the practice analysis forms the basis for both the CBT and SARE. Using 
responses from practicing IPs, content domains and measurable areas of knowledge and skill are 
identified and are used to develop the framework for the examination. Subject matter experts assist with 
development of new test questions (items) on a continual basis that are reviewed by those with 
expertise in psychometrics, a branch of science that deals with design, administration, and measurement 
of knowledge through test questions. Questions fall into one of three difficulty levels: recall questions 
which test the memorization or recall of specific information; application questions which require some 
interpretation of data or information provided; and analysis questions which may require problem solving 
or the assimilation of several pieces of information in order to derive the answer. Each question is then 
pretested through inclusion as an unscored (unmarked) item in current certification examinations. While 
candidates are made aware that 15 of the 150 questions on each exam are pretest items, they are not 
aware of the specific questions that are pretest items. After pretest items have been trialed, they are 
evaluated to determine their utility and reliability as part of the certification process. The evaluation 
relies on statistical and psychometric methods to determine whether pretest items are appropriate for 


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use in future examinations. Questions that fail to demonstrate value in the certification process are not 
included in future examinations. The interval between the development of a new question to its inclusion 
as a scored item on an examination spans several (6-12) months. All questions belong to CBIC and are 
copyrighted. 

The certification examination itself undergoes continuous evaluation and improvement. Because changes 
such as updates to surveillance definitions or evidence-based recommendations occur frequently in the 
profession, questions are reviewed on a continual basis to ensure that they remain current. Outdated 
questions are discarded. If substantive changes are needed in order to update a question, the revised 
item is returned to the pretest question phase and reevaluated for inclusion in the examination. This 
process of continuous assessment and improvement demonstrates the attention and commitment to the 
certification process to ensure that it is a contemporary and valid assessment for competence. 

Passing scores are determined based on the responses that are provided for each of the 135 scored 
questions. The method used to set the minimum passing score for both the CBT and SARE is the 
Angoff method, in which subject matter experts have determined how many correct answers are 
required for a competent candidate to successfully complete the examination. A candidate's ability to 
pass the examination depends on the knowledge and skill he or she displays, and not on the 
performance of other candidates. The actual passing score may change slightly for each version of the 
examination, to account for the slight variation in the difficulty of questions on each version of the 
examination. Historically, approximately 60 percent of first-time CBT test takers and over 95 percent of 
those taking the SARE are successful. 

PREPARING FOR THE EXAMINATION 

Candidates should use the current content outline to guide them about domains of study and to develop 
a study plan. It is important to recognize that examination content is based on information obtained from 
the practice analysis and will assess all relevant domains of skill and knowledge that certified IPs 
require, even though all elements of the examination may not seem to be directly relevant to every 
individual taking the exam. 

A number of different strategies have been employed by successful certificants. A list of references that 
are recommended for study is available on the CBIC website ( www.cbic.org ). The APIC Study Guide is 
a valuable resource for many candidates. Local study groups, which may be organized by APIC or 
IPAC-Canada chapters, may be helpful. Candidates may need to dedicate more study time to areas in 
which they have less experience or are less proficient, and may need to ask for guidance from local 
experts in these domains. Additional resources and educational offerings, available locally, through APIC 
or IPAC-Canada chapters or other professional societies, or from CBIC and APIC, may help to address 
areas of weakness or deficiency. 

APPLYING FOR AND TAKING THE EXAMINATION 

First-time applicants must meet the eligibility criteria outlined by CBIC. Once certified, all certificants are 
automatically eligible for recertification at 5-year intervals. If certification expires, then individuals may 
only become certified again if eligibility criteria are met, as though applying for the examination for the 
first time; this may mean that a previously certified IP whose certification has expired and whose role 
has now changed may not be eligible to certify again. The CIC®designation may only be used by those 
whose certification with CBIC is currently valid. 

Details regarding eligibility criteria, the application process, fees, and scheduling the examination are 
available in detail on the CBIC website ( www.cbic.org ). 


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Conclusions 

Competent practice is, and should be, the goal for all professionals. Approaching competence with a 
framework that identifies areas of expected practice outcomes, a roadmap for achievement, and a 
method for determining success are hallmarks of a well-designed process. Ensuring that infection 
prevention and control programs are led by competent professionals serves to protect the patient, 
family, caregivers, and healthcare personnel while actively demonstrating a commitment to high quality 
performance. This step also serves as a demonstration to the public that this group of well educated, 
expertly trained, and capable professionals is openly dedicated to ongoing improvement and validation 
of practice. 

ACKNOWLEDGMENTS 

The authors would like to express their appreciation for the contributions made by Corrianne Billings, 
Lisa Caffery, Jessica Dixon, Gemma Downham, and Sandy Hyman. 

References 

[1] Friedman C, Curchoe R, Foster M, et al. APIC/CHICA-Canada infection prevention, control and epidemiology: 
professional practice and standards. Am J Infect Confro/2008 Aug;36(6):385-389. 

[2] Floyt KS, Proehl JA. Competencies and certification for advanced practice nurses in emergency care. Adv Emerg 
Nurse J2009 Apr-Jun;31(2):91-93. 

[3] Murphy DM, Hanchett M, Olmsted RN, et al. Competency in infection prevention: a conceptual approach to guide 
current and future practice. Am J Infect Control2012 May;40(4):296-303. 

[4] Van Vugt M, Plogan R, Kaiser RB. Leadership, followership and evolution: some lessons from the past. Am 
Psychol2008 Apr;63(3):182-196. 

[5] Scriven M, Paul S. Critical thinking as defined by the National Council for Excellence in Critical Thinking, 1987. 
Foundation for Critical Thinking website. 2013. Available at: http://www.criticalthinkinq.org/paqes/defininq-critical- 
thinkinq/766 . 

[6] Feltovich F, Fabrey LJ. The current practice of infection prevention as demonstrated by the practice analysis survey 
of the Certification Board of Infection Control and Epidemiology, Inc. Am J Infect Confro/2010 Dec;38(10):784-788. 

[7] Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, Pediatric Infectious 
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America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society 
(PIDS). Infect Control Hosp Epidemiol2012 Apr;33(4):322-327. 

[8] Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services. 
The Health Information Technology for Economic and Clinical Health (HITECH) Acf.Health IT website. 2013. Available 

at: http://www.healthit.qov/policv-researchers-implementers/health-it-leqislation-and-regulations . 

[9] Saint S, Howell JD, Krein SL. Implementation science: how to jumpstart infection prevention. Infect Control Hosp 
Epidemiol2010 Nov;31 

Suppl 1 :S14-S17. 

[10] National Research Council. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational 
Research. Washington, DC: The National Academies Press, 2013. 


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[11] Pronovost PJ, Berenhotlz SM, Needham DM. Translating evidence into practice: a model for large scale knowledge 
translation. BMJ2008 Oct 6; 

337:a1714. 

[12] Hanchett M. Preventing CAUTI: a patient centered approach. Prevention Strategist2(y\2 Autumn:42-50. 

[13] Agency for Healthcare Research and Quality (AHRQ). Selecting health outcome measures for clinical quality 
measuremenf.AHRQ website. 2013. Available at: 

http://www.aualitvmeasures.ahra.aov/tutorial/HealthOutcomeMeasure.aspx . 

[14] Fitzpatrick JJ, Campo TM, Graham G, et al. Certification, empowerment, and intent to leave current position and the 
profession among critical care nurses. Am J Crit Care2010 May;19(3):218-226. 

[15] Coleman EA, Coon SK, Lockhart K, et al. Effect of certification in oncology nursing on nursing-sensitive outcomes. 
Clin J Oncol Nurs2009 Apr;13(2):165-172. 

[16] Kendall-Gallagher D, Blegen MA. Competence and certification of registered nurses and safety of patients in 
intensive care units. J Nurs Adm20^0 0ct;40(10 Suppl):S68-S77. 

[17] Boltz M, Capezuti E, Wagner L, et al. Patient safety in medical-surgical units: can nurse certification make a 
difference? Medsurg /Vurs2013 Jan-Feb;22(1):26-32,37. 

[18] Kendall-Gallagher D, Aiken LH, Sloane DM, et al. Nurse specialty certification, inpatient mortality, and failure to 
rescue. J Nurs Scholarsh20’\'\ Jun;43(2): 188-194. 

[19] Pogorzelska M, Stone PW, Larson EL. Certification in infection control matters: Impact of infection control department 
characteristics and policies on rates of multidrug-resistant infections. Am J Infect Control20']2 Mar;40(2):96-101. 

[20] Saint S, Greene MT, Olmsted, R, et al. Perceived strength of evidence supporting practices to prevent health care- 
associated infection: results from a national survey infection prevention personnel. Am J Infect Confro/2013 
Feb;41(2):100-106. 

[21] Carrico RM, Wiemken T, Westhusing K, et al. Health care personnel immunization programs: an assessment of 
knowledge and practice among infection preventionists in US health care facilities. Am J Infect Confro/2013 

Jul ;41 (7):581—584. 


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APIC 

XrVT OF INFECTION CONTROL 
i txV I AND EPIDEMIOLOGY 


Education and Training 


Author(s): Irena Kenneley, PhD, APRN-BC, CIC 
Assistant Professor 

Case Western Reserve University 
Cleveland, OH 

Published: November 26, 2014 


Abstract 

Few infection preventionists receive formal instruction in how to present intellectually exciting learning- 
centered activities, to lead engaging discussions, or to relate to adult learners in the healthcare 
environment in ways that promote motivation and independent learning. The learning environment in 
healthcare settings is unique because of the diversity of healthcare personnel. Diversity includes 
characteristics such as age, cultural background, ethnicity, education, and learning styles. Basic 
principles of adult learning have applied to the infection preventionist in the role of clinical educator with 
all types of healthcare personnel. These principles are applicable in a variety of clinical settings. 
Healthcare's complexity and rapid changes require that training activities also address issues of literacy, 
cultural diversity, cross-training, and technological advances. Successful educational activities in 
healthcare should be informed by learning theories and the educational needs of the learner population, 
the institution, and the community as they relate to infection prevention. Infection preventionists should 
provide an appropriate climate for learning as well as demonstrate creativity and flexibility. 

Key Concepts 

• The most basic goal of healthcare education and training is to improve job skills and competence. 

• Workplace training in healthcare is a response to emerging issues in the field and tends to be 
problem-focused. 

• Learning retention increases when immediate application follows instruction. 

• Workplace education is business-driven and tied to administrative and financial goals, productivity, and 
the need to benchmark against the best professional practices. 

• Needs assessments or performance improvement studies identify deficiencies in knowledge, skills, or 
attitude and serve as the basis for educational program development. 


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• An educator should develop a well-defined plan for each learning experience that includes goals, 
objectives, and appropriate teaching methods. 

• Education and training should be linked to a facility's organizational vision, mission, and values. 

Background 

Education and training today is more exciting and challenging than ever before. Now infection 
preventionists (IPs) facilitate learning for healthcare personnel (HCP) of all ages, from many different 
lifestyles, ethnic and cultural backgrounds, with different generational characteristics, and, most 
importantly, learning styles.lEducation expertise is needed to assist HCP in the development of critical 

thinking skills to prepare them in the provision of the best and safest care for patients, visitors, other 
staff members, and for themselves. Educational philosophies have not been stagnant—they change as 
the larger social system matures—but they do provide foundations on which educational pedagogies are 
built .1 

Learners are most successful when they are able to link new knowledge to the familiar. Providing 
education that addresses gaps in practice and complies with training that is mandated because of 
federal, state, or accreditation requirements poses significant challenges to HCP and the organization .i 

With healthcare becoming one of the most heavily regulated of American industries, employees can 
anticipate an increase in institutionally mandated education. Healthcare facility administrators must 
ensure organizational compliance to minimize the threat of litigation or heavy fines for code violations. 
For the employer and employee alike, the business side of operations must be balanced with a clear 
understanding of organizational principles and values. Corporate compliance emphasizes that actions 
reflect the fabric of the organizational value system .i 

Educators routinely use benchmarks to demonstrate the positive influence of educational interventions 
on worker performance. 2 Tracking performance outcomes and measuring effectiveness of training has 

become the norm. 2 Leaders recognize that to succeed in the new millennium, the goal for healthcare 

institutions is to develop employees to their highest level of performance while recognizing the diversity 
of the workforce. HCP are encouraged to acquire new knowledge and, in turn, share their expertise with 
others. 1,2 

Because of reengineering and reorganization, healthcare organizations are experiencing an increase in 
the growth of part-time and temporary staff, contract labor, students, and volunteers. Coupled with 
increasing average age, learner audiences will include a more diverse group with a wider array of 
worker expertise. This will require a new approach to engage the learner and will therefore require new 
teaching methods used by the educator. As part of performance improvement, HCP will assume more 
responsibility for workplace learning. Currently, performance appraisals in some facilities indicate the 
expectations for mastery of certain infection prevention skills. 2 ,3With increased emphasis on facility 

report cards and public reporting of healthcare-associated infections (HAIs), the expectation is that more 
facilities will improve their compliance with infection prevention policies and procedures in employee 
appraisals .3 

Effective workplace training initiatives will be directly linked to the implementation of professional and 
regulatory standards, as well as facility policies and procedures. IPs will develop training that is more 


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focused on skill development that is competency-based. Competencies describe worker skills, 
knowledge, and the mindset necessary to achieve effective job performance. These elements detail the 
specific outcomes or job expectations as indicated by role, work setting, and professional standards and 
facility-accepted benchmarks or best practices in the field. The focus is on the demonstration of 
individual competence by benchmarking rather than a comparison to fellow HCP or peers. For example, 
HCP may be required to demonstrate their abilities in sterilization, disinfection, and specimen handling, 
based on their job duties. The benchmarking process also ensures ongoing evaluation and monitoring.3 

The impact of bioterrorism and new and unusual disease presentations, such as West Nile disease, 
monkeypox, severe acute respiratory syndrome, swine flu, Middle East respiratory syndrome, and avian 
flu, have increased the need for timely, thorough educational activities.4,sAs new problems surface, new 

solutions will evolve and an educational program will be needed. To address these increasing demands, 
IPs must develop new strategies based on evidence-based practices to readily adapt to the learning 
needs of their audiences and their facilities. Similarly, with the recognition that adults learn in a variety 
of ways, IPs are expanding their teaching skills beyond the traditional lecture and slide show method. 
Incorporating technology in the educational change process is revolutionizing the way people are taught. 
Computer-based training can enable employees to manage time effectively and learn to be more 
independent and self-directed learners. An important goal is to assess and make recommendations for 
expanded and appropriate use of technology. 2,3 


Basic Principles 

MAJOR GOALS IN TEACHING 

IPs are in a unique position to have a direct impact on the facilitation of learning for HCP and staff. In 
the process of evaluation, IPs see their work in action, see the changes they affect and, in so doing, 
witness firsthand their goals and the goals of the institution coming to fruition. Learning outcomes for 
HCP should include increased competence in identifying problems, critical thinking, managing existing 
situations, and coping effectively with stress.6 

The facilitation of learning can be by oral or written methods, and there are formal and informal 
methods. There are many factors the IP must take into consideration when addressing goals in 
teaching, such as: gender, cultural background, age, and the organizational culture. Other 
considerations in teaching goals are the accessibility of information, communication channels, clarity of 
message, flow control and information load, and methods to measure teaching effectiveness. The 
provision of opportunities for HCP to network with other personnel and share their expertise within the 
organization will expand the learner's creative abilities .7 

PRINCIPLES OF ADULT LEARNING 

In order to plan and implement educational activities in healthcare, IPs need to know how adults learn 
best. Acknowledgment of the special needs of adult learners is also important. Finally, the six 
characteristics of adult learners must be taken into consideration for successful educational programs. 
Adult learners are autonomous and self-directed. They have a foundation of life experiences and 
knowledge and are goal oriented by nature. Adult learners are relevancy oriented and practical in 
healthcare settings. Adult learners need to be shown respect. For each characteristic, there are 
implications for you, the IP.4,5,6,7 


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Malcolm Knowles, a leader in the field of adult education, developed this framework describing how 
adults learn differently than children. His framework is summarized in Table 3-1.8 

Educators must also be aware of and plan to confront common roadblocks to the learning process. One 
area that has been overlooked until recently is considering the specific needs of young adults in the 
workforce. This is an important concept because of the wide variation in ages of the adult learner. 

Young adult learners may need to be approached differently from an educational perspective from the 
more mature adult. Recognizing the differences in technological capabilities and how younger adults 
view their job responsibilities will require that teaching methods be adjusted as a means of engaging 
this group. 

BLOOM'S TAXONOMY 

Bloom's taxonomy was created in 1956 under the leadership of educational psychologist Dr. Benjamin 
Bloom in order to promote higher forms of thinking in education, such as analyzing and evaluating, 
rather than just remembering facts (rote learning). This taxonomy of learning behaviors can be thought 
of as "the goals of the learning process." That is, after a learning episode, the learner should have 
acquired new skills, knowledge, and/or attitudes.9 


Table 3-1 Framework for Adult Education 

Conditions of Adult Education Principles of Teaching 

The learners feel the need to learn. • The IP exposes the learners to new possibilities for self- 

fulfillment. 

• The IP helps the learners clarify their own aspirations for 
improved performance. 

• The IP helps the learners diagnose the gaps between 
their present level of performance and their desired 
level. 

• The IP provides physical conditions that are comfortable 
(as to seating, temperature, ventilation, lighting, 
decorations) and conducive to interaction (circle or small 
groups at tables). 

• The IP accepts the learners as persons of worth and 
respect their feelings and ideas. 

• The IP builds relationships of mutual trust and 
helpfulness with and among the learners by encouraging 
cooperative activities and refraining from inducing 
judgmental attitudes or competitiveness. 

The learners perceive the goals of the learning experience to be • The IP exposes their own feelings and contributes their 

their goals. resources in the spirit of mutual inquiry. 

The learners accept a share of the responsibility for planning and • The IP involves the learners in a mutual process of 
operating the learning experience. formulating learning objectives in which the needs of the 

learners, of the IP, of the institution, of the subject 
matter, and of society are taken into account. 

• The IP shapes their thinking about the options available 
in designing learning experiences and the selection of 
methods and materials and involve the learners in 
deciding among these options jointly. 


The learning environment is characterized by physical comfort, 
mutual respect and trust, mutual helpfulness, freedom of 
expression, and acceptance of differences. 


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The learners participate actively in the learning process. • The IP helps the learners organize themselves (teams, 

training projects, and so on) to share responsibility in the 
process of mutual inquiry. 

• The IP helps the learners exploit their own experiences 
as resources for learning through such techniques as 
group discussion, case method, and projects. 

The learning process is related to and makes use of the experience • The IP gears the presentation of their own resources to 
of the learners. the levels of experience of the learners. 

• The IP helps the learners to apply new knowledge to 
their personal experiences and thus makes the learned 
material more relevant and integrated. 

The learners have a sense of progress toward their goals. • The IP involves learners in developing mutually 

acceptable progress toward the learning objectives. 

• The IP helps the learners develop and apply procedures 
for self-evaluation according to these criteria. 


The Three Types of Learning 

The committee identified three domains of educational activities or learnings 


1. Cognitive: mental skills (Knowledge) 

2. Affective: growth in feelings or emotional areas 
(Attitude or Self) 

3. Psychomotor: manual or physical skills (Skills) 

This compilation divides the three domains into subdivisions, starting from the simplest behavior to the 
most complex. The divisions outlined are not absolutes and there are other systems or hierarchies that 
have been devised in the educational and training world. However, Bloom's taxonomy is easily 
understood.9 

During the 1990s a new group of cognitive psychologists, led by Lorin Anderson (a former student of 
Bloom), updated the taxonomy to reflect relevance to 21st century work. Figure 3-1 shows the two 
graphics, the revised and original taxonomy. Note the change from nouns to verbs associated with each 
level .10 




Figure 3-1. 

Bloom's taxonomy. .... 

View Image 

Table 3-2 


New Version Old Version 


Table 3-3 

Learning 

Behaviors 

Goal of the Learning Process 

Remembering:Can 

Define, duplicate, list, memorize. 

the learner recall 

recall, repeat, reproduce state 

or remember the 


information? 



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UnderstandingiCan 

the learner explain 
ideas or concepts? 

Classify, describe, discuss, explain, 
identify, locate, recognize, report, 
select, translate, paraphrase 

Applying:Can the 

learner use the 

information in a 
new way? 

Choose, demonstrate, dramatize, 
employ, illustrate, interpret, 
operate, schedule, sketch, solve, 
use, write 

Analyzing:Can the 
learner distinguish 
between the 
different parts? 

Appraise, compare, contrast, 
criticize, differentiate, discriminate, 
distinguish, examine, experiment, 
question, test 

Evaluating:Can the 
learner justify a 
stand or decision? 

Appraise, argue, defend, judge, 
select, support, value, evaluate 

CreatingiCan the 
learner create new 
product or point of 
view? 

Assemble, construct, create, 
design, develop, formulate, write 


ACTIVE LEARNING 

Often, as IPs prepare an educational session, they are thinking about what should happen in the 
session, and it is easy to go back to what we know and how we were taught—basically, the traditional 
pattern of "lectures and discussions." But to create significant learning, there are new tools and new 
kinds of teaching and learning activities. It is necessary to understand, and then learn, how to 
incorporate more active learning into our education and training programs. 11 


Active learning is one of the more powerful ideas to emerge in the literature on teaching and learning in 
the 1990s.nln essence, the concept of active learning supports research that shows: Learners learn 

more and retain their learning longer if they acquire it in an active rather than a passive manner. What 
do we mean by "active learning"? Active learning is described as involving the learners in doing things 
and thinking about the things they are doing. These "doing things" can be involving learners in activities 
such as debates, simulations, guided design, small group problem solving, case studies, and so forth. 
For example, when a learner is listening to a lecture or reading a textbook or work manual, they are 
receiving information and ideas—an important part of the learning process—but these also are relatively 
passive learning activities. To make learning more active, the overall learning experience needs to be 
enhanced by adding some kind of experiential learning and opportunities for reflective dialogue .11 


Learning is not a spectator sport and the more actively engaged learners are, the more learning and 
retention takes place. Different instructional methods have greater rates of retention. 

The pyramid in Figure 3-2 demonstrates the proportion of people who learn best from selected 
instructional methodologies. Most of us learn best when we're actively involved in the learning process 
(discussion groups, practice, teaching others ).12 


Figure 3-2. 

Learning retention: active learning versus passive learning. 
National Training Laboratories (Bethel, Maine)n 


View Image SI 


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Learning 

Retention 


5% LeCtUr- 

10% Iteading 


% 

j\ 


20% Audio-Vitual k $ 
30% Demonstration 
TO', Discussion Group 


75% 


90^-c 


Practice by Doing 

Teach Others/Immediate 
Use of Learning 


- 2 . 


• Group problem-solving 


There are several strategies to consider 
depending on your audience and the purpose of 
your training. Some of the strategies are 
particularly relevant for diverse audiences. For 
example, role-playing could be incorporated by 
having participants practice talking to a teacher, 
administrator, or someone else about 
noncompliance with hand washing that is 
occurring.n,i30ther active learning strategies 

include: 

Quizzes 

Games 

Role-playing 

Brainstorming 


• Case studies 


• Simulation 


Side Bar: 

An example of a simulation learning activity: Create a simulation of an event, such as a methicillin- 
resistant Staphylococcus aureus (MRSA) outbreak in the neonatal intensive care unit, and practice 
responding to it. 

An example of the case study format: Have learners tackle Clostridium difficile scenarios taking into 
account Transmission-based Precautions, the environment of care, and exploring ways to promote 
optimal infection prevention activities. 

The foundation of evidence-based education (EBE) is analogous to evidence-based practice (EBP) in the 
scientific literature. In order for an educational offering to be optimal, it is necessary to follow the 
principles of adult learning theory and active learning. One of the important points for IPs to keep in 
mind when preparing an educational program is the synthesis of evidence in an organized framework 
that can be evaluated in order to draw conclusions or to develop newer appropriate activities.i4Societal 

directives insist on patient safety mandated through accrediting and governmental agencies with an 
ever-increasing emphasis on education and training.3,4 


EDUCATIONAL PROGRAM DEVELOPMENT 


Program Content 

Needs assessments or performance improvement studies identify deficiencies in knowledge, skills, or 
attitude and serve as the basis for educational program development. Assessing educational needs of 
the learner population, the institution, and the community, as it relates to infection prevention, is the first 
step in effective program planning.is 

Improving learning transfer to workplace practices must be a high priority in the planning phase. 
Educators must link the previous knowledge and experience of participants to what is being taught, 


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using workplace situations to illustrate major points. The program content must be relevant, practical, 
and "doable" and should include practice sessions as a part of class activities. IPs should plan for 
reinforcement of knowledge in the work setting and ensure support from key leaders and supervisors. 16, 

17 

Fortunately, the infection prevention learning needs of HCP, the institution, and the community at large 
are interrelated. HCP participants need to know principles of infection control and prevention and current 
policies and procedures that govern infection prevention practice in their assigned areas of work. Facility 
administrators need to know how to develop institutional guidelines, policies, and procedures in 
accordance with accrediting and regulating groups. The citizenry or community populations need to 
know the factors that influence the development and spread of infectious disease. 17 


Healthcare Personnel Competence 

To be successful, it is important that HCP be able to transfer new knowledge into practice and be able 
to consistently apply this knowledge regardless of the setting. Work done by Gebbie and Merrilli8,i9 

defined a competency as a combination of knowledge, attitude, and skills. Hsu et aUtook this a step 

further and asserted that competency statements are broad and need to be aligned with specific 
statements of activity or performance that are measurable. Carrico et al.sapplied this to infection 

prevention and provided the first set of competencies devoted to infection prevention among hospital- 
based HCP. The competency statements they propose include the following: 

1. Describe the role of microorganisms in disease. 

2. Describe how microorganisms are transmitted in healthcare settings. 

3. Demonstrate Standard and Transmission-based Precautions for all patient contact in healthcare 
settings. 

4. Describe occupational health practices that protect HCP from acquiring infection. 

5. Describe occupational health practices that prevent HCP from transmitting infection to a patient. 

6 . Demonstrate ability to problem solve and apply knowledge to recognize, contain, and prevent 
infection transmission. 

7. Describe the importance of healthcare preparedness for a natural or human-made infectious 
disease disaster. 

The competency statements also contain specific measurable activities, or terminal objectives. These 
statements and activities may be used to provide the framework for HCP education across all 
disciplines. Further, this framework can be incorporated into the educational setting as part of the basic 
curriculum for the healthcare student. Competency-based education can be used as a basis for 
assessing training needs from a didactic approach and in support of classroom and hands-on learning 
approaches. 

Assessing Educational Needs 

Performing a needs assessment will enable the educator to ensure the focus of an educational activity 
is relevant and reasonable for the target learner populations.isStudy results will determine the interests 

of the group, readiness to learn, professional experience, and the cognitive differences in clinical 
reasoning.i6Findings can be used to develop course goals and objectives and to assess the efficacy and 

impact of the educational activity. 


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Methods that can used to determine educational needs of the leaner population include the following: 

• Learner self-assessment: The learner develops a self-achievement model and compares the present 
situation to the standard. 

• Focus group discussion: Learning needs are assessed in small groups with members assisting each 
other to clarify needs. 

• Interest-finder surveys: These are data-gathering tools, such as checklists or questionnaires. 

• Test development: Tests can be used as diagnostic tools to identify areas of learning deficiencies. 

• Personal interviews: The educator consults with random or selected individuals to determine learning 
needs. 

• Job analysis and performance reviews: These methods provide specific, precise information about 
work and performance. 

• Observational studies: Direct observation of personnel working can be performed by quality 
management analysts or IPs (e.g., hand-washing study in critical care units). 

• Review of internal reports: Incident reports, occupational injury and illness reports, and performance 
improvement studies can be reviewed to determine specific learning needs of healthcare providers. 16, 

17 


Goals and Objectives 

The educator controls the learning experience with a well-defined plan using goals, objectives, and 
appropriate teaching methods. Goals are statements that communicate the intent of the curriculum and 
provide a direction for planning the education session. Expectations are clearly defined in terms of time 
and available resources. 

Once the purpose of the program is established, the educator determines the specific actions the 
learner will perform as a result of instruction. These actions are known as instructional objectives. There 
is no single, correct method or style for writing educational objectives, but there are general guidelines 
that should be followed. Properly written instructional objectives describe learner outcomes in 
measurable terms and use action verbs such as discuss, describe, demonstrate, compare, or evaluate. 

Objectives describe each task or behavior the learner will be able to perform after completing the 
course, as well as the conditions under which each task or behavior will be performed. An educator 
includes objectives at various cognitive levels and with varying degrees of complexity. The most common 
model of increasingly more complex thinking is demonstrated by Bloom's taxonomy. The three lowest 
levels are: knowledge, comprehension, and application. The three highest levels are: analysis, synthesis, 
and evaluation. The taxonomy is a hierarchy with each level subsuming the ones below. In other words, 
a student functioning at the "application" level has also mastered the material at the "knowledge" and 
"comprehension" levels. These cognitive levels are shown in Figure 3-1. 

Learning Environment 

One of the most important roles of the educator is to provide an atmosphere of mutual respect, one 
that is friendly, informal, and supportive. Eye contact, addressing students by name, listening without 
interrupting, and acknowledging the validity of problems or opinions expressed are characteristics of an 
effective teacher. Embarrassing the student or the use of intimidation or sarcasm is counterproductive to 
sharing information and resolving learning deficiencies. 17,20 


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The educator must also take steps to create an environment that is comfortable and conducive to 
learning. The learning space should be private and congenial, with careful consideration to seating, 
room temperature, and lighting. The room should be properly arranged for learning transactions and 
should maximize physical and sensory potential.i7As a courtesy, let participants know the location of 

restrooms and the timing of breaks. 

The educator should eliminate distractions and try to control or decrease the noise level; ask that 
pagers and cell phones be turned to the inaudible range. The sounds of nonparticipants talking or 
laughing and sound of repairmen or custodial workers can be distracting to participants. 

Provide audiovisual equipment that is in working order and ready for use. It is helpful to have a packet 
of information that describes the proper use and types of microphones, control switches, pointers, and 
any other technical devices in the room. Allow time for speakers to see the room and equipment before 
their presentation. Provide a designated person at the learning site to troubleshoot any facility or 
technical problems should they occur.is,i9Test equipment before the learning session begins to ensure 

its functionality. 

Common Classroom Settings 

The traditional classroom setup with straight rows of desks does not promote interaction. Better ways to 
arrange the classroom exist .21 

The horseshoe shape is an all-purpose setup. It allows face-to-face participant contact and provides a 
writing surface. The educator and training equipment are positioned for easy visibility. Participants can 
be positioned inside the "U" for group activity. 

Team style is achieved by arranging small tables and chairs around the room. It facilitates group activity 
and interaction. Some participants will have to turn their chairs around when the class reconvenes, but 
this is acceptable. 

Conference table style is best if the arrangement is circular or square; if it is rectangular, it creates a 
"person's table" effect and a sense of formality. The facilitator is placed at the head of the table in the 
power position. 

Chevronor fishbone style , a repeated V arrangement, creates less distance between participants and 
provides greater visibility of the educator. If the traditional classroom style is the only choice available, 
grouping the chairs in pairs promotes partnering. Provide enough space between rows to allow for the 
formation of quartets. 

Stadiumor auditorium style is a limiting environment for active training. Participants can be paired for 
brief activities requiring a learning partner, although it may seem awkward to participants .21 


Enhancing the Learning Experience 

An important factor for a successful program is having a well-regarded, experienced educator who 
facilitates the learning process by making course content understandable and memorable while 
engaging the participants. The learning experience should begin with an exercise that focuses on the 
learner and makes it personally relevant. The educator should define or redefine terms with respect to 
historical or current thinking and use examples or anecdotes to underscore major points. Major points 
should be emphasized with variations in voice intonation, speed, gestures, or overall body language. 


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Repetition should be used, repeating the same point in different ways. At the end of the learning 
session, summarize and review the major points. 

The educator should engage the student in interaction with the material through activities such as 
dialogue, demonstration, role-play, and use of real-life examples. Audiovisual aids, such as slides, 
models, videos, posters, and whiteboards, are excellent support for the learning environment as well. 

USING LEARNING STYLE ASSESSMENTS TO FACILITATE LEARNING 
OUTCOMES 

Knowing a learner's learning style will assist both the adult learner and IP to maximize the learner's 
learning experience. There are many learning style assessment tools that can be employed for the 
purpose of improving educator understanding of the mix of learning styles within the diverse HCP 
population. This information can then be used to determine the best teaching modalities to use with a 
particular group. 

Three Common Learning Assessment Tools 

1. The Kolb learning style inventory places the learner into one of four learning styles: 

a. Accomodative—prefers concrete experience and active experimentation 

b. Assimilative—prefers abstract conceptualization and reflective observation 

c. Divergent—prefers concrete experience and reflective observation 

d. Convergent—prefers abstract conceptualization and active experimentation 22 

2. The Dunn, Dunn, and Price Productivity Environmental Preference Survey (PEPS) is a self¬ 
diagnostic instrument and assesses four categories: 

a. Environmental—preference for light, noise, emperature, etc. 

b. Sociological—preference for studying alone or in groups 

c. Physical—visual, auditory, or kinesthetic 

d. Emotional—responsibility, persistence, and motivation23 

3. The VARK inventory is an online assessment for auditory, visual, or kinesthetic preferences in 
learning.24The VARK can be found at the end of this chapter in the Supplemental Resources 

section. 

Cognitive and learning style analyses have a special role in the process of personalizing instruction. 

Style elements are relatively persistent qualities in the behavior of individual learners. They reflect 
genetic coding, personality, development, motivation, and environmental adaptation. Second only to the 
more flexible teacher role, the assessment of learner learning style, more than any other element, 
establishes the foundation for a personalized approach to learning: for adaptive instructional strategies, 
and for the authentic evaluation of learning. 

TEACHING STYLES 

Another variable that contributes to educator effectiveness in the clinical area is teaching style. Grasha's 
classification defines teaching styles as expert, formal authority, demonstrator, facilitator, and delegator. 
25The characteristics of each style are unique and are listed in Table 3-2. 

Individual teaching styles involve behaviors and have a direct effect on the teaching-learning 
environment. The following are examples of behaviors and their effects on learners: 


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• Making eye contact encourages learners to participate in the session 

• Positive facial expressions that elicit a positive learner response, such as head nodding, can assist 
learners in feeling comfortable dialoguing in class, whereas negative gestures, such as frowning, can 
discourage learner participation 

• Vocal tone is very important and can easily portray underlying feelings and encourage or discourage 
learner participation 

Table 3-4 Teaching Styles Characterized by Grasha 


Teaching Style 

Characteristics 

Expert 

IPs use their vast knowledge base to inform learners and challenge them to be well prepared. This can be 
intimidating to the learner. 

Formal Authority 

This style puts the IP in control of the learner's knowledge acquisition. The IP is not concerned with learner- 
educator relationships, but rather focuses on the content to be delivered. 

Demonstrator or 

Personal Model 

The IP coaches, demonstrates, and encourages a more active learning style. 

Facilitator 

Learner-centered, active learning strategies are encouraged. The accountability for learning is placed on the 
learner. 

Delegator 

The IP role is that of a consultant and the learners are encouraged to direct the entire learning project. 


Most educators rarely use just one teaching style. Most educators use a variety of styles, even within a 
single teaching-learning session. This mixed approach appeals to the variety of learning styles and has 
been shown to improve learning outcomes. Reflection on the type of style one uses most encourages 
self-understanding and may serve to improve teaching effectiveness. 

EVALUATION 

Evaluation of educational programs is conducted to determine: (1) learner progress toward achieving 
program objectives; (2) effectiveness of the educational process to foster learner learning; and (3) 
accomplishment of the mission of the institution to prepare HCP for optimal infection prevention and 
control activities. 

Program evaluation is necessary to measure change and growth in the learner. 26 Data collected from 

participants before, during, and/or after an education program is needed to demonstrate efficacy and 
impact. Feedback should be shared with learners, managers, and facilitators to demonstrate progress 
made and provide direction for further improvement. Specific program elements that should be 
evaluated include appropriateness of program design, adequacy of teaching and instructional resources, 
and the knowledge, skills, and attitudes learned by the participants. A representative sample of data 
from the learner population is necessary to provide evidence of successful learning. 16,26 

A decision on how evaluation results will be used should guide the development of instruments, 
questions, and protocols. A course manager can use this information to make decisions about what to 
improve, expand, or delete from future presentations. Findings can also be used by the organization to 
determine which types of programming work best and appeal to the learner, as well as measure 
response to innovative or controversial ideas. Evaluations also serve to provide program justification and 
accountability, often required by funding agencies, sponsors, or accrediting bodies. 


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Evaluation Methods 

The educator may use evaluation at different points within the program development process. Formative 
evaluation is conducted during the planning of the educational session to provide immediate feedback 
and to allow appropriate changes to be made. Summative evaluation occurs after the program is 
completed to determine impact and overall effectiveness. 27 

Various methods can be used to determine learning outcomes. Data collected by pretest and posttest 
before and after an intervention are used to measure change in individual or group understanding of the 
content. These tools help guide instruction by serving as a course outline. This type of evaluation 
design allows the educator to assess the appropriateness of the material presented for a particular 
audience and whether learning has occurred. 27 

Additional methods of evaluation include direct observation of practice, noting behavioral changes that 
are a result of the course (e.g., demonstration of proper use of protective barriers). Exit questionnaires 
are frequently used to gather information about the overall success of the program, asking for feedback 
on all aspects of the course, including objectives, presenter, quality of teaching aids, and the learning 
environment. One-on-one interviews may be used to collect more in-depth information from participants 
regarding understanding of concepts or preferences for program design. 27 

If a change in on-the-job behavior is anticipated as an outcome of the training exercise, the instructor 
should work with appropriate supervisors to determine whether the learning objectives were met. It may 
be necessary to review program content and learner reaction to this content with their supervisor. It is 
the supervisor's responsibility to advise the learner if job performance does not meet expectation. The 
educator may be involved in any additional coaching needed by the learner on the invitation of the 
specific supervisor. 

Whatever evaluation methodology is used, the data must be gathered, tabulated, and analyzed to 
assess impact and make recommendations for curriculum revision before the next presentation. 
Evaluation measurements must be consistent with the objectives established for the educational 
program. Caution must be exercised when doing evaluations to prevent development of the Hawthorne 
effect, in which practice improves when the participant is aware that he or she is being observed. This 
underscores the importance of using unannounced and unobtrusive methods to monitor practices such 
as hand hygiene. 27 

INNOVATIVE INSTRUCTIONAL METHODS 

Positive Deviance 

Positive deviance is based on the observation that in every community there are certain individuals or 
groups whose uncommon behaviors and strategies enable them to find better solutions to problems than 
their peers, while having access to the same resources and facing similar or worse challenges. 28 

The positive deviance (PD) approach is an asset-based, problem-solving, and community-driven 
approach that enables the community to discover these successful behaviors and strategies and develop 
a plan of action to promote their adoption by all concerned .28 

For example, in healthcare, PD bridges the gap between what HCP know and what they do. They know 
infection control protocols, but they may not follow them consistently. PD processes enable frontline staff 


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to identify practices that already work, and to discover for themselves the best ways to foster adherence 
at all times by all persons who come in contact with patients. 

Creating Network Maps 

Smart networks are described as networks that have a large core of overlapping clusters of individuals 
from different units in an organization, and a sizeable loose periphery of connections inside and outside 
the organization that bring in new ideas. The strategy of the PD MRSA prevention partnership is to use 
the social change process PD to enable frontline staff in different roles to work together across different 
disciplines and units to identify infection control practices that are already working. 

Members of smart networks also collaborate to eliminate barriers to infection prevention, and to discover 
and implement ways to ensure that all persons who come in contact with patients adhere to all 
prevention control protocols at all times. To discover whether PD helped move a hospital system toward 
smart network structure, employees involved in the initiative went through a network mapping process. 
This included a survey that asked two types of questions. 

The first set of questions, called attribute questions, measure characteristics of the survey takers—such 
as role, unit, and age. These provide different color options for the nodes or squares on the network 
map representing individuals. For example, on the maps shown in Figure 3-1, nodes represent the units 
and show how people tend to interact more with others in their own unit. The second set of questions, 
network questions, are used to track and measure the relationships among survey takers. 

Survey participants were asked the following questions to develop five network maps: 

• Initial network: With whom did you work on MRSA prevention before the PD MRSA initiative began? 
This is the beginning or baseline collaboration network. 

• Current network: With whom have you worked on MRSA prevention since the initiative began? This 
shows changes in the collaboration network. 

• Innovation network: From whom have you gotten new ideas or inspiration that helped your MRSA 
prevention efforts? This shows the degree and flow of innovation. 

• Project network: List projects/activities and the people who are working on them. This shows how 
specific projects link people. 

• Potential network: Who would you like to work with in the future on MRSA prevention? This helps 
organizations see helpful new relationships and plan for the future. 

• Social network analysis metrics: The following metrics were developed by Valdis Krebs, a noted 
social network consultant and researcher, and colleague of June Holley. These metrics are used to 
measure network health. 

° Awareness: Who knows what is happening in the network, and how likely is it that information will 
spread? This measures whether the network is well-configured for information flow. 

° Connector: Who links people who would not otherwise be connected? How connected are different 
parts of the network? This measures the connectivity in the network. 

° Integration: Who are positioned to be network leaders, and what is the overall health of the 
network? This measures overall leadership and network health. Healthy networks have many 
participants, many lines of interaction and links among individuals and units, connections to 
expertise and resources across units, and some links outside the organization. They are not 
dependent on one-way communication from a few leaders. 


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Holley J. Charting Pathways to Change: Mapping the Positive Deviance MRSA Prevention Networks at 
the VA Pittsburgh Healthcare System's Acute Care and Long-Term Care Facilities Shows Promise. 
Washington, DC: Plexus Institute, 2007. 

The selection of teaching style and instructional method depends on the resources of the institution and 
the preference of the educator. The educator understands and uses the basic principles of adult 
learning and has the ability to tailor the instructional method and teaching style to the specific type of 
learner population represented in the education setting (e.g., nonclinical employees, nursing assistants, 
resident physicians). 

Lectures 

Lecturing has been defined as "telling learners something they could not otherwise read in a book or 
review article." In this format, the speaker is able to cover a lot of material in a limited amount of time 
in both small and large groups. Learning theory tells us that lectures are not the optimal method for 
students to learn or retain new knowledge. The success of a lecture program depends on the relevance 
of the information to the learner and the presenter's public speaking ability. This type of program is 
enhanced when time is reserved for questions and answers or some other extended discussion between 
the speaker and participants. 

More complex or voluminous materials can be presented in a symposium format, in which three to six 
lectures are presented in turn by content experts on various phases of a single subject or problem. This 
activity includes open discussion with the audience. Forum or panel formats can also be used. In a 
forum, one or more speakers engage in free and open discussion about the subject. A panel usually 
comprises four to seven presenters with special knowledge on the subject. Both of these styles of 
presentations can be combined to create an interesting program. 

Computer-based Training 

A computer-based training module presents content in a logical sequence and guides the student to 
achieve specific learning objectives. This high-quality instruction combines the multidisciplinary expertise 
of the subject matter experts with innovative instructional design such as the use of video, audio, and 
other interactive formats to teach key concepts. Learner participation, immediate feedback, and colorful 
graphics are also attractive features that hold the student's attention. 

Providing training via computers is versatile in that it can be used independently by individual learners 
or by groups in a classroom setting with an educator available to answer questions. This methodology 
provides a learning alternative for persons unable to attend scheduled classes.3 

Lack of computer skills may be a drawback for some learners asked to complete computer-based 
training.3This method requires sufficient technical support because there may be installation and other 

capacity issues that come up. It may also be a challenge to ensure computer access for the target 
audience. It is reported that in many institutions, it's difficult for HCP to set aside the time needed to 
complete a module and there may also be a limited number of computer workstations available. 

Using Web-based instruction to address infection prevention education and training can be of significant 
value. This learning opportunity provides access to materials for HCP whose workload demands are 
unpredictable and changing. It allows HCP to address their own educational and practice gaps at times 
that are most convenient for their work and home life schedules. 


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Games 

Well-structured games can facilitate learning and may be used as a "gathering tool" to introduce a 
concept or as a testing tool to access learning. Examples of simple games are table-top quizzes during 
safety presentations and word search and word scramble puzzles. 29 


Mass Training Delivery Systems 

For wide-scale institutional education, many facilities have worked with companies to personalize 
educational materials using an organizational intranet. 

TRAIN- THE- TRAINER 

The train-the-trainer method may be an option for institutional education in situations in which large 
numbers of staff must be educated over a relatively short span of time. Leader guides are used to train 
those persons responsible for implementing the program and providing the ongoing staff in-service and 
continuing education. Leader guides are simply written and presented in a concise, systematic format, 
providing curriculum goals and objectives, course outline, instructional methods, references, and 
evaluation. 

Role-play or Reenactment 

The dramatic teaching strategy of role-play or reenactment uses a situational learning experience and 
the technique of simulation to allow the learner to experience firsthand a professional dilemma as a 
spectator or as a participant. It can be used as a springboard for discussion in conjunction with a forum, 
panel, or symposium or as a building block for conferences and seminars with a focus on problem¬ 
solving methods. It also can be used in the development of an educational video. 29 


Case Studies 

Case studies can be used as a training method to help bridge the learning gap between theory and 
actual practice. The method builds on a variety of learner skills: analytical, critical, and interactive. 
Learners explore multiple solutions and enhance creativity and problem-solving approaches often using 
a discussion-based format. 

Mentoring Programs 

Mentoring is seen as a cost-effective way to upgrade and cross-train the workforce. In some 
organizations, there are formalized programs in which respected senior managers advise and groom 
promising candidates. Some employers encourage volunteer mentors from within the organization to 
assist with employee development and learning. Regardless of the program, mentoring is seen as a 
process in which the mentor and candidate work together to discover and develop the 
protege's abilities. 1, 3, 5 

Mentors may be nominated, but, in general, the mentoring relationship is voluntary and remains active 
as long as it is beneficial. With correct preparation and managerial support, virtually anyone can become 
a mentor. Mentor and learner matching should be done by linking persons with assessed developmental 
needs with leaders in the organization having the needed expertise. Mentors and their charges may 
complete a self-assessment of leadership skills to identify areas of expertise and growth opportunities. 

Mentors should be good listeners, focus on learner needs, be willing to share knowledge and expertise, 
and be capable of brutal honesty. Mentoring is practiced in partnership with an attitude of generosity, 


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openness, and trust, with both parties contributing freely.i, 3, sThe mentor may be at the same or a 

higher level than the learner, but is recognized as seasoned or experienced in the area or subject 
matter. The information revealed in the mentoring relationship is considered privileged and does not 
influence performance appraisals. Mentors teach, explore alternatives, inspire, act as a sounding board, 
build confidence and capability, facilitate learning, ask questions, listen with compassion, develop skills, 
create ownership, provide a challenge, act as a model, and explore potential. They provide the learner 
with tools, support, and structure to achieve more than what he or she might be able to do otherwise. 

Simulation 

The use of simulation is deeply rooted in HCP training. Laboratories in which nurses learned the 
fundamental skills in patient care were often performed in a simulated setting where learning occurred 
before direct practice. In recent years, the use of simulation has advanced to the point of using human 
patient simulators as well as combining patient simulators with role players. The goal is to create a 
controlled learning environment that closely resembles the practice setting. This process facilitates use 
of practical and critical thinking skills on the part of the participant and serves to protect the safety of 
the patient. 

One example relevant to infection prevention may be the creation of a mock isolation room. The goal 
may be to increase the awareness of the nursing staff regarding common infection prevention infractions 
that may occur during the provision of care. This would enable the participant to practice use of 
isolation precautions and personal protective equipment, as well as the infection prevention activities 
necessary to care for a patient with invasive devices such as intravenous lines, indwelling urinary 
catheters, feeding tubes, and mechanical ventilation. Environmental cleaning, preparation and provision 
of patient meals, performance of phlebotomy, and patient interaction are other examples of activities 
that can be honed and objectively evaluated in the simulated environment. 

Educational Cart 

Demonstration carts provide a portable means of displaying educational materials on a specific situation 
for diverse employee populations working various shifts. For example, the unit could be designed to 
display and store handouts from the Centers for Disease Control and Prevention (CDC) and various 
types of respiratory protection that are available for use. Other types of information available on the cart 
could include material on tuberculosis epidemiology and transmission, and skin testing protocol, along 
with diagnosis and treatment regimens, a patient teaching checklist, and an algorithm of infection 
prevention measures. 

DVDs, CDs, and Videotapes 

DVDs, CDs, and videotapes are useful formats for self-learning projects and can be obtained from most 
facility education and staff development departments, libraries, or resource rooms. Typically, these are 
inexpensive materials that can be easily transported and are user-friendly. Mobile units are helpful for 
on-site, "just-in-time" learning situations. Materials that are professionally produced and facility-specific 
may not be cost effective, depending on facility usage and how fast the information becomes outdated. 

It is wise to have several subject matter experts review a DVD, CD, or videotape before purchase to 
ensure the information presented reflects the infection prevention practices of the facility. Short video 
clips are helpful to demonstrate a point or to open the door for group discussion. 

Self-instructional Modules 


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Self-instructional modules are written to provide another alternative for the visual learner. They provide 
a self-paced approach to allow the learner to explore new information autonomously or in small groups. 
Modules should be user-friendly and simply written. 

Distance Learning 

Interactive audio, graphic, and video conferencing systems allow for the exchange of information from 
one location to another through electronic communications. This innovative technology can also link 
healthcare providers in remote or underserved areas to specialty patient care services for fast medical 
consultation. It is also valuable in providing for ongoing employee education, training, and collaboration 
with other healthcare professionals. 30 

The overall effectiveness of the educational intervention depends on training and knowledge of 
equipment use. On-site communication experts or technologists should be available to provide speaker 
tips, "hands-on" instruction, and written materials for facilitating an effective presentation. If possible, 
observe distance learning in session and garner advice from experienced presenters. 

Some points to remember when arranging a distance learning session are as follows: 

• Determine the number of sites that will be "online" for your presentation. 

• Know the number and location of necessary equipment such as cameras, monitors, microphones, or 
telephones. Practice using the equipment and test it before the start of the program. 

• Introduce at least one spokesperson at each site. Try to call participants by name. 

• Create a group comfort level and mutual regard for participants. Overcome the intimidation of 
electronic equipment by assisting each other. 

• Engage participants in a balanced discussion. Involve on-site and off-site participants equally. Avoid 
side discussions. 

• Ask a representative from each site to report transmission difficulties with sound or vision. If there will 
be a delay, it is best to announce it. If an off-site group must disengage for any reason, provide an 
explanation and continue with the presentation or discussion. 

• Allow for breaks and questions. The speaker voice quality and the ability to pace and pause during 
the presentation are important skills to master for an effective delivery. 

• Plan a debriefing session after the conference to assess program strengths and areas for 
improvement. 

• Provide evaluations for off-site participants. Ask their assistance in providing feedback information to 
improve the quality of the program. 

Conclusions 

Adults bring life experiences into the learning situation. Life changes can motivate adults to engage in 
new learning experiences. Learning new skills and knowledge takes time for integration to occur. Action 
plans, accountability, and follow-up all increase the likelihood that learning will take place. Theories of 
education are only a guide to the instructor. Effective instructors will be flexible, eclectic, and creative in 
the instructional presentations they make. Presentations must be perceived as interesting, useful, and 
relevant for the adult learner to willingly participate in the activity. Measurements of learning should be 
made over time to identify future training needs. 


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Future Trends 

In many situations, the learners who are novices in the domain of infection prevention and control are 
more expert in the uses of new communication technologies than their coworkers. So the workforce 
today in fact depends on a diverse set of participants, when the strengths of each are of benefit to the 
others. The increasing diversity of the workforce is predicted to become a strength; namely, as a source 
of innovation, rather than a barrier. 

In the provision of healthcare there has been rapid change, and the IP's expertise is a double-edged 
sword. IPs must frequently reexamine their expertise, to be sure that it is still valid given the changes 
that have occurred. Often the specific facts and skills have a relative short "half-life." In these domains 
of rapid change, there is also power in naivete—novices will suggest ways of thinking about the domain 
that may not have been useful previously, but may be useful given changes. Because those approaches 
were not useful previously, they may be automatically blocked out by experts. Again, with frameworks 
made available by new technologies, there are ways to involve learners in activity in the world outside of 
education in a way that is useful to the other participants in the activity. 

Increasing demands for workplace education to address a complex and rapidly changing healthcare 
environment will require additional skills and resources for IPs. Reliance on outside sources of credible 
education will become more necessary as more unusual disease processes become evident. 
Collaboration with outside sources of education will also need to be enhanced. Nontraditional formats for 
education will have to be used to accommodate the changing needs for timely information on infection 
prevention practices and procedures. 

International Perspective 

Concepts of transcultural care need to be incorporated into successful educational activities. Cultural 
backgrounds will affect the ability of the learner to participate in learning activities and accommodate 
new skills and ideas. Transcultural education will encompass different perceptions based on geography, 
gender, religion, social status, age, sexual orientation, and ethnic diversity. Care must be taken to 
minimize miscommunication when the instructor and the learners do not speak the same language. The 
development of a mentor relationship as a cultural quality control will help guide the instructor to 
develop appropriate educational activities. 

Supplemental Resources 

Agency for Healthcare Research and Quality (AHRQ). Evidence-Based Practice Centers. AHRQ website. 
2008. Available at: http://www.ahra.aov/clinic/epc/ . 

Brown BL. New Learning Strategies for Generation X. ERICDigests website. 1997. Available at: 

http://www.ericdiaests.Org/1998-1/x.htm . 

Fleming N. A Guide to Learning Styles. VARK-Learn website. 2013. Available at: http://www.vark- 
learn.com/enalish/index.asp 

Positive Deviance Initiative (PD). What is positive deviance? PD website. 2014. Available at: 

http://www.positivedeviance.org/ . 


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What's Your Learning Style? Available at: http://www.edutopia.orq/multiple-intelliaences-learnina- 
stvles-auiz 

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[18] Gebbie K, Merrill J, Sanders L, et al. Public health workforce enumeration: Beware the "quick fix". J Public Health 
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72-79. 

[19] Gebbie K, Turnock B. The public health workforce, 2006: New challenges. Health /4ffa/rs2006;25(4):923-933. 

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[21] Noble H. The challenges of setting up a teaching event for health-care staff. Br J A/urs2009;18(6):374-377. 

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APIC 

XnVT OF INFECTION CONTROL 
i txV I AND EPIDEMIOLOGY 


Accrediting and Regulatory Agencies 


Author(s): Kelley Boston, MPH, CIC, CPHQ, FAPIC 
Senior Associate 

Infection Prevention & Management Associates 
Houston, TX 

Published: October 3, 2014 


Abstract 

This chapter presents administrative issues for infection prevention and control programs and addresses 
historical and current pressures affecting accrediting and regulatory agencies at all levels that in turn, 
affect infection prevention and control programs. A brief description of the agencies, their relationships 
to each other, and their impact on infection prevention and control programs is provided, including a 
table with contact and website information for retrieval of more information. 

Key Concepts 

• The focus on patient safety, quality of care, risk reduction, and improving patient outcomes continues 
to develop in healthcare organizations across the United States. It includes all aspects of infection 
prevention and control programs with a broad scope that encompasses the program's integration with 
other departments in their healthcare organization, including nursing care, employee health, facilities 
maintenance and management, and quality improvement. 

• Regulatory agencies, such as Centers for Medicare & Medicaid Services and accrediting agencies, 
such as The Joint Commission, encourage organizations to place more emphasis on infection 
prevention and control programs. 

• Historically, the Agency for Healthcare Research and Quality was charged with developing a plan to 
reduce adverse patient outcomes and improve the safety of healthcare personnel and patients. The 
Agency, in collaboration with the Centers for Disease Control and Prevention's Division of Healthcare 
Quality Promotion, focuses on knowledge transfer (immediately usable information) and 
implementation of healthcare-associated infection prevention strategies. 

• There has been increasing collaboration among federal agencies and new partnerships among federal 
agencies, private, and professional organizations to develop performance measures and to improve 
consumers' ability to compare healthcare delivery and patient outcomes. 


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• To function effectively, infection preventionists require a basic knowledge of the key agencies. 

• Most agencies with an impact on infection prevention and control programs emanate from the 
executive branch, primarily within the Department of Health and Human Services and its major 
divisions of the Public Health Service: the Centers for Disease Control and Prevention, including the 
National Institute for Occupational Safety and Health and the Agency for Toxic Substances and 
Disease Registry, the U.S. Food and Drug Administration, Health Resources and Service 
Administration, National Institutes of Health, Agency for Healthcare Research and Quality, and the 
Centers for Medicare & Medicaid Services, formerly known as the Health Care Financing 
Administration. Other major agencies affecting infection prevention and control programs include the 
Department of Labor's Occupational Safety and Health Administration and the Environmental 
Protection Agency. 

Background 

Extraordinary change occurring in the healthcare field has had a profound effect on current infection 
prevention and control programs. In the past, regulatory changes have driven related policy 
development of infection prevention and control programs (see 1. Infection Prevention and Control 
Programs ). Competitive forces have provided such an impact that even voluntary accrediting agencies 
have effected program changes in all care sites, including acute care, extended care, pre- and post¬ 
hospital care, inpatient rehabilitation, home care, and ambulatory care clinics. Examples of historical 
changes affecting infection prevention and control programs throughout the 1990s and the present 
include: 

• The Joint Commission (TJC) standards published first in 1976 required hospitals seeking accreditation 
to have infection control programs; standards now place new emphasis on infection preventionand 
control. Another initiative TJC requires for accreditation, the National Patient Safety Goals (NPSG), 
escalated attention to healthcare-associated infections (HAIs) by including hand hygiene and reduction 
of device- and procedure-associated infections among current NPSGs and further expanded HAI 
issues in the 2009 standards. 

• The evolution of the HIV/AIDS epidemic challenged healthcare to meet the medical needs of a 
growing number of very ill patients and to address occupational concerns and educational needs of 
all healthcare personnel. The emergence of HIV/AIDS as more "chronic disease" has had new impact, 
with a stepped-up emphasis on early HIV testing in the maternal and newborn population as well as 
in adults. 

• SENIC: Publication of the results of the 10-year (1974-1983) Study on the Efficacy of Nosocomial 
Infection Control (SENIC) established the efficacy of hospital IPPs.i 

• Development of the prospective payment system (PPS), a fixed payment hospital reimbursement 
system provided a financial motivation for hospitals to prevent costly infections in the late 1990s. An 
even greater impact occurred 10 years later that focused on HAIs: The Inpatient Prospective Payment 
System required limited payments for certain hospital-associated conditions, which included HAIs. 

• Managed care systems and PPSs for long-term care continued exerting pressure on resizing systems 
throughout the 1990s. This included redesign of infection prevention and control programs for 
systems well beyond the borders of acute care settings. Ambulatory care systems are receiving new 
attention from the Department of Health and Human Services (HHS), both in Centers for Disease 
Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS), given the 
number of outbreaks of device-associated infections in nonacute settings. 


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• Threats from emerging pathogens and bioterrorism had a major impact on infection prevention and 
control programs beginning in October 2001, a month after the 9/11 attack on the Pentagon and 
World Trade Center. The era escalated with the dramatic event of Bacillus anthracis transmission 
through the U.S. postal system, continuing with current planning responses to potential biological 
agents, such as smallpox. Infection prevention and control programs played a major role in 
developing strategies for Vaccinia vaccination programs as part of the federal smallpox response 
plan. These major events, along with responding to new and emerging pathogens such as severe 
acute respiratory syndrome (SARS), added a major shift in priorities for programs already concerned 
with potential threats of an overdue influenza pandemic. HHS and the Department of Homeland 
Security have escalated plans for preparing for pandemic influenza under an all-hazards approach to 
natural and humanmade disasters. Infection prevention and control programs have seen a significant 
increase in their involvement and infection preventionist participation in emergency preparedness 
activities. 

• Since the SENIC study, the single most important federal initiative to focus attention on the prevention 
of HAIs in healthcare facilities has been the 2009 publication of The Department of Health and 
Human Services National Action Plan to Prevent Healthcare-Associated Infections. The plan 
development involved all DHHS internal agencies and involved input from key stakeholders and public 
comment. The plan identifies key strategies for reducing HAIs, and sets proposed metrics and targets 
for acute care, ambulatory surgical hospitals, long-term acute care, and end-stage renal disease care 
facilities. This initially targeted reduction of HAI in acute care facilities, but the scope has expanded to 
include nonacute and ambulatory care settings. In response, all 50 states have released HAI 
reduction action plans. 

• A major payment system change termed value based purchasing was established in 2010 under the 
Affordable Care Act. It provides incremental payments in a risk-adjusted approach, based on quality 
of care, implementation of evidence-based best clinical practices, and patients" experience of care. 

• CMS requires public reporting of HAIs at the federal level, and at the state level in more than half of 
U.S. states. Reporting plans vary but generally focus on device-associated infections including central 
line-associated bloodstream infections (CLABSI) and Foley catheter-associated urinary tract infections, 
surgical site infections (SSIs), methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, 
and healthcare personnel influenza vaccination. 

Basic Principles 

The impact of the Institute of Medicine's (IOM) reports beginning in 1999 has had a dramatic effect in 
healthcare, focusing on the importance of the healthcare environment's effect on patient outcomes. 2 The 

Agency for Healthcare Research and Quality (AHRQ) was charged with developing a plan to reduce 
adverse outcomes and improve the safety of personnel and patients. This focus on medical and patient 
safety continues to develop in healthcare organizations across the United States and includes all 
aspects of infection prevention and control programs. Given this emphasis on patient safety, accrediting 
agencies, such as TJC, encourage organizations to place increasing focus on infection prevention, as 
evident in the most recent infection prevention standards revision, including the 2005 CMS collaboration 
with the Association for Professionals in Infection Control and Epidemiology (APIC) in revising the 
Interpretive Guidelines (IG) for the infection prevention standards. One very visible result has been 
increasing collaboration among federal agencies, as well as increasing partnerships between the federal 
agencies and the private sector. These changes have a profound impact on infection prevention and 
control programs. For example, federal agencies concerned with quality or performance standards and 


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guidelines (e.g., CMS, AHRQ, CDC) are partnering with private and professional organizations, such as 
the American Hospital Association (AHA) and the National Quality Forum (NQF). The goal of the 
collaborative effort is development of similar performance measures in each care setting, improving the 
consumer's ability to compare healthcare delivery across similar care sites. One such initiative is the 
public reporting on several quality measures in hospitals, nursing homes, and home care, all of which 
include infection-related complications. As the focus on patient safety, improved outcomes, and 
transparency continues to expand and to function effectively, infection preventionists (IPs) require a 
basic knowledge of the key agencies and an understanding of their relationship to each other and to 
their specific program. 

An enormous amount of activity occurred in terms of public reporting of HAIs since 2005. MRSA caught 
the attention of consumers and received intense media coverage; this was followed by similar attention 
to the problem of Clostridium difficile infection (CDI). The impact on the public was vast, with an 
increasing demand for accountability from healthcare on prevention and control of HAIs. Most states 
now mandate public reporting, congressional hearings and reports from the Government Accounting 
Office (GAO) have led to an intensified focus on HAI reduction or elimination at the federal level, and 
healthcare facilities are required to publicly report HAI outcomes and prevention practices, such as 
healthcare personnel influenza vaccination rates. This data is available and visible to the general public. 
Increased public awareness of HAI and infection prevention and control programs has led to increased 
visibility of infection preventionist and infection prevention and control programs and greater demand for 
accountability for patient outcomes. Never before has infection prevention been so highlighted or 
scrutinized so publicly. 

Accrediting and Regulatory Agencies 

Against this backdrop of HAI awareness, the federal and state agencies remain a powerful influence, 
and their relationships within the government structure are described briefly here. A summary table of 
key selected agencies, committees, or programs (Table 4-1) accompanies the following explanatory 
remarks, provides a quick reference guide for easy access, and includes the current address for online 
resources available at the time of publication. 

GOVERNMENTAL AGENCIES AND ACTIVITIES 

Governmental agencies can be placed organizationally in terms of their relationship to the three 
branches of the U.S. government. That is, agencies fit as extensions of the legislative, executive, or 
judicial branches of governmental structures.3The accompanying table highlights the fact that most 

agencies with an impact on infection prevention and control programs emanate from the executive 
branch , primarily within HHS; a key HHS agency is CMS, formerly known as the Health Care Financing 
Administration, although it is not designated as a member of the HHS's Public Health Service (PHS). 
Major divisions of HHS identified as members of the PHS include the CDC, especially the Division of 
Healthcare Quality Promotion (DHQP), the CDC's National Institute for Occupational Safety and Health 
(NIOSH), and the CDC's Division of Tuberculosis Elimination; and the Agency for Toxic Substances and 
Disease Registry (ATSDR). Other PHS agencies important to infection prevention and control programs 
include the U.S. Food and Drug Administration (FDA), Health Resources and Service Administration 
(HRSA), National Institutes of Health (NIH), and AHRQ. Other independent, key agencies of the 
executive branch or cabinet level departments include the Department of Labor's Occupational Safety 
and Health Administration (OSHA), the Environmental Protection Agency (EPA), the U.S. Department of 
Agriculture (USDA), the Department of Transportation (DOT), and the Department of Homeland Security. 


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The legislative branch had two agencies important to Congress for communication; today this is primarily 
the GAO because the Office of Technology Assessment has been closed and other resources provide 
those services. 


Table 4-1 Regulatory Compliance: Accreditation, Regulatory, and Professional Agencies and National 
and State Agencies With an Impact on Infection Prevention Programs 


Major 

Specific 

Programs or AHJ* 

Telephone or Online Resource 

F 

Department 
or Agency 

Agency 



\ 



National Center for 

http://www.cdc.gov/ncezid/ 


Executive 

Centers for 

Preparedness, 


c 

Branch 

Disease Control 

Detection, and 


r 


and Prevention 

Control of Infectious 


s 

Health & 

Human 

(CDC) 

Diseases (NCPDCID) 



Services: 

Selections from 




Public Health 

Coordinating 




Service (PHS) 

Center for 
Infectious 

Disease (CCID) 





CDC 

Division of 

http://www.cdc.gov/ncidod/dhap/index.html 

r 



Healthcare Quality 
Promotion (DHQP) 


a 


CDC 

DHQP 




CDC DHQP's Healthcare http://www.cdc.gov/hicpac/index.html h 

Infection Control a 

Practices Advisory 
Committee (HICPAC) 


CDC National Center for http://www.cdc.gov/vaccines/pubs/ACIP-list.htm h 

Immunization and a 

Respiratory Diseases' 

Advisory Committee 
on Immunization 
Practices (NCIRD's 
ACIP) 


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CDC 

National Center for 
HIV/AIDS, Viral 
FHepatitis, STD, and 

TB Prevention 
(NCHHSTP) 

Advisory Council for 
the Elimination of 
Tuberculosis (ACET) 

ww.cdc.gov/tb/default.htm 

http://www.cdc.gov/maso/FACM/facmACET.htm 

h 

a 


CDC 

National Institute for 

http://www.cdc.gov/niosh/about.html 



Occupational Safety 


F 


and Health (NIOSH) 


F 

t 

CDC 

Coordinating Office 

http://www.bt.cdc.gov 

F 


for Terrorism 


a 


Preparedness and 




Emergency Response 




(COTPER) 




Agency for Toxic 

http://www.atsdr.cdc.gov 

F 

CDC 

Substances and 


C 


Disease Registry 


c 

ATS DR 

(ATSDR) 


t 

Distinct from but 



t 

overseen by the 




CDC 



F 

Food and Drug 


http://www.fda.gov 


Administration 

FDA 


F 

(FDA) 





Safe Medical Device 


E 


Act (SMDA) 


( 


Safe blood supply 


c 


(both the FDA and 


c 


CDC) 


s 


Food safety for all 


c 

1- 


but meat, poultry, 


a 


and eggs 


F 


Vaccine Adverse 


l 


Event Reporting 




System (VAERS) 




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Health Resources 
and Services 
Administration 
(HRS A) 


HRSA 

Health Delivery 
Services 


http://www.hrsa.gov 


t 


Agency for AHRQ guidelines http://www.ahrq.gov 

Healthcare 

Research and 

Quality (AHRQ) 


National 

Institutes of NIH http://www.nih.gov/ 

Health (NIH) 

Improve health of http://www.nlm.nih.gov/ 

nation 14 research 

institutes; National 

Library of Medicine 

(NLM) 


Health and 

Human 

Services 3 


Centers for 

Medicare and 

Medicaid 

Services (CMS) 

CMS 

Oversight for 
Medicare/Medicaid 

http://www.cms.gov 

(access for Medicare databases for long-term care, home care) 

http://www.cms.hhs.gov/HospitalAcaCond/01 Overview.asp 


Participation 

conditions 

(Hospital-associated conditions [HAI]) 


Payment system 



Environmental 

Independent 



Protection 

agency 

Regulated medical 

http://www.eoa.gov 

Agency (EPA) 


waste 

http://www.eoa.gov/osw/nonhaz/industrial/medical/mwfaas.htm 



Resource 

Conservation and 

http://www.eoa.gov/oooad001/dis tss docs/dis-Ol.htm 



Recovery Act (RCRA) 

http://www.eoa.gov/oppad001/regoolicv.htm 



Medical waste 

Antimicrobial hotline: 1-703-308-0127 



Disinfectants for 

hard surfaces 




Antimicrobial 

pesticides 



( 


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Department 
of Labor 
(DOL) 

Occupational 

Health and 

Safety 

Administration 

(OSHA) 

OSHA standards 

General safety and 
health standards 

httD://www.osha.gov F 

htto://www. osha.gov/SLTC/bloodborneDathogens/index.html E 

F 

e 


DOL-OSHA 


§ 


DOL-OSHA 

OSHA's standards 

httos://www.osha.gov/SLTC/tuberculosis/ 

F 



Respiratory 
protection: Std 
1910.134 

|\ 

t 

c 



General Industry 
Respiratory 

Protection Standard 
(GIRPS) 

c 

r 

a 

r 

a 

Department 

of 

Transportation 

(DOT) 

Independent 

agency 

DOT 

Research and Special 
Programs 

Administration (RSPA) 

htto://www.dot.gov 

F 

F 

t 

r 

c 

Department 
of Agriculture 
(USDA) 

Independent 

agency 

Food Safety 

Inspection Service 
(FSIS) 

htto://www.fsis.usda.gov/ 

F 

F 


USDA 


f 

f 

Department 

of 

Homeland 
Security (DHS) 

Independent 

agency 

DHS 

Emergency 
preparedness and 
response (DHS) 

tto://www.dhs.gov/index.shtm F 

Legislative 

Branch 

Congress 

Congress: 
Government 
Accounting Office 
(GAO) 

GAO provides 

Congress with 
information on 
public spending 

htto://www.gao.gov F 

Search on Infections 1 

Congressional 

Information 

Agency 

Expenditures: 

GAO 




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Nongovernmental 



Voluntary 

accreditation: 

TJC: outgrowth of 

httD://www.iointcommission.org/ \, 

Accreditation 

TJC, AOA, DNV 

AHA, ACS, AMA, 




ADA, ACP 

httD://www.osteoDathic.org/ t 

The Joint 



F 

Commission 


AOA 

htto://www.dnv.us c 

(TJC) 



f 



DNV 

i 

American 



3 

Osteopathic 




Association 




(AOA) 




Det Norske 




Veritas 




Healthcare 




Inc. (DNV) 




National 


NCQA: collaboration 

httD://www. ncqa.org 

Committee on 

Nongovernmental 

as of 1998 with 

\, 

Quality 

accreditation 

JCAHO and AMAP for 


Assurance 


quality 

F 

(NCQA) 

Other: HMO 

council/measurement 

r 


NCQA: Accredits 


F 


HMO and 


F 


outpatient 


g 


settings 


f 



CAP and COLA: 


Laboratory 

CAP 

certify laboratories 

htto://www.cap.org \, 



that TJC recognizes 


College of 

COLA 

as "deemed status" 

httD://www.cola.org S 

American 



1, 

Pathologists 




(CAP) 




Commission 




on Office Lab 




Accreditation 




(COLA) 





Disease control; 

Infectious disease 

URL is state specific 

States 

laboratory 

control services of 

F 


services 

some type 


Department(s) 



C 

of public or 




community 



7 

health 



|\ 

5 

c 

Agencies 

Enforcement of 

Licensing bureau 

URL is state specific 

charged with 

CoP with 


F 

health care 

Medicare/ 



facility 

Medicaid; OBRA 



enforcement 

and ECF; 


/ 


construction 


c 


codes; office of 


F 


fire safety; 




enforce CLIA 




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Agencies 

Medical waste 


charged with 

program 

State plan 

enforcement 

of medical 

waste 

incinerators 


Environmental 
quality of some type 

State-Plan- 

OSHA 

State plan 

State 

Occupational 

Occupational Safety 

Occupational 

health, radiation 

and Health 

Safety and 
Health Acts 

health 


Labor 

Department 

General safety 

State plan 

or 

Occupational 
Safety, Health 
Act 

Labor: general 
safety program 

Labor division 


Jurisdiction may 

Communicable 

Local 

be separate from 

disease agency 

Local health 
department 

state health 
departments 


Fire marshal; 

Departments of 

Food, water, waste 

water 

public health or 


jurisdiction 

city 



URL is state specific 


URL is state specific 


URL is state specific 


URL is state specific and may have local links 


URL is state specific and may have local links 


*AHJ = Authority Having Jurisdiction. 

HHS = organizational chart accessed February 2, 2009: http://www.hhs.ciov/about/orachart/ . 


Department of Health and Human Services 

Centers for Disease Control and Prevention 


The CDC's mission is to collaborate to create the expertise, information, and tools that people and 
communities need to protect their health—through health promotion; prevention of disease, injury, and 
disability; and preparedness for new health threats. The CDC seeks to accomplish its mission by 
working with partners throughout the nation and the world to monitor health, detect and investigate 
health problems, conduct research to enhance prevention, develop and advocate sound public health 
policies, implement prevention strategies, promote healthy behaviors, foster safe and healthful 
environments, and provide leadership and training.4 The CDC responded to a national anthrax mail 


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scare in 2001 and continues to provide critical direction and leadership for all aspects of programs 
involving bioterrorism and related agents, such as preparing for pandemic influenza. The Emerging 
Pathogens program has developed important initiatives in recent years, ranging from study of new 
pathogens to that of new levels of antimicrobial resistance, for example, vancomycin-resistant 
Staphylococcus aureus. The CDC provided major leadership with the World Health Organization in 
responding to the SARS epidemic, identifying a new variant of corona virus with enormous public health 
implications around the world. As noted in Table 4-1, the CDC has important advisory committees; the 
Healthcare Infection Control Practices Advisory Committee (HICPAC) publishes a number of infection 
prevention guidelines that are applied to appropriate settings. Although many consider their 
recommendations "standard setting," they are not regulatory in nature nor are they enforced as 
regulatory standards. However, CMS and TJC, as well as other accrediting agencies, base their 
enforcement activity on these gold standard guidelines. Another advisory committee important to 
infection prevention and control programs is the Advisory Council for the Elimination of Tuberculosis, 
which is closely related to tuberculosis prevention guidelines. Several key divisions and committees 
within the CDC are described here. 


The Division of Healthcare Quality Promotion (Formerly the Hospital Infections Program) 


The CDC's DHQP is one of seven divisions within the National Center for Emerging and Zoonotic 
Infectious Diseases and is composed of one activity (program implementation and integration), the 
Immunization Safety Office, and three main branches: Clinical and Environmental Microbiology 
Laboratory, Prevention and Response, and Surveillance. Among these activities, DHQP (1) conducts 
research, surveillance, investigations, and laboratory and field studies of HAIs, as well as research on 
methods of preventing and controlling infections; (2) collects and processes clinical and environmental 
specimens; (3) rapidly diagnoses disease and identifies unusual sources of infection; (4) evaluates 
medical devices as sources of infection; and (5) analyzes and reports antimicrobial resistance. 


• Dialysis: DHQP has primary responsibility for the prevention of dialysis-associated disease, including 
guidance for equipment disinfection and other means of prevention of disease transmission. The 
Dialysis Surveillance Network (DSN), a voluntary national surveillance system monitoring bloodstream 
and vascular infections in adults and pediatrics, was initiated by the CDC in 1999. 

• Disinfection and sterilization: DHQP develops disinfection and sterilization procedures and 
recommends broad strategies for proper use of sterilants, disinfectants, and antiseptics to prevent the 
transmission of infection in the healthcare environment. This includes both environmental and medical 
device issues. 

• National Surveillance of Nosocomial Infections and National Healthcare Safety Network: National 
Surveillance of Nosocomial Infections began in 1970 and was conducted through DHQP's National 
Nosocomial Infections Surveillance System (NNIS) to estimate the magnitude and nature of HAIs and 
to provide hospitals with comparative data to evaluate prevention and control efforts. DHQP has 
incorporated NNIS into a Web-based knowledge system identified as the National Healthcare Safety 
Network (NHSN), which accumulates, exchanges, and integrates relevant information and resources to 
protect patients and promote healthcare safety. NHSN includes the elements of NNIS, National 


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Surveillance System for Healthcare Workers, and DSN (see "Dialysis" above), forming an integrated 
data repository at the CDC. With the explosion of state-mandated public reporting, NHSN is now used 
in more than 11,000 hospitals across the United States and is expected to grow further, including 
more focus on electronic capture and transfer of information within HHS. 

• Bloodborne pathogens: DHQP conducts studies on the nature, frequency, and risk factors for 
transmission of bloodborne pathogens in healthcare and develops guidelines to reduce these risks. 


Division of Healthcare Quality Promotion-Healthcare Infection Control Practices Advisory 
Committee (Formerly Hospital Infection Control Practices Advisory Committee) 


HICPAC was established in 1991 to provide guidance to the CDC and develop guidelines on specific 
infection prevention practices in healthcare. Guidelines are published cooperatively on the CDC website 
and in professional journals, including the American Journal of Infection Control. Drafts are usually 
published for comment in the Federal Register. The guidelines are used as major resources for policy 
development and modified for facility-specific needs; they are not regulatory in nature but healthcare 
organizations will generally be expected to justify practices that deviate from established guidelines. In 
light of the intense federal and state attention to preventing and controlling HAIs, HICPAC has taken a 
lead role within the HHS HAI action plan and has been streamlined into an important communication 
role among HHS, CDC, and the healthcare community. 


National Center for Immunization and Respiratory Diseases-Advisory Committee on 
Immunization Practices 


Advisory Committee on Immunization Practices (ACIP) was established in 1964 to provide guidance to 
the CDC's National Center for Immunization and Respiratory Diseases on the most appropriate 
application of antigens and related agents (e.g., vaccines, antisera, and immunoglobulins), as well as to 
recommend specific immunization practices and strategies to improve national immunization efforts. 
Recommendations are published and updated in the Morbidity and Mortality Weekly Report (MMWR) as 
well as in periodic MMWR Recommendations or Summaries. The 2011 Immunization of Health-Care 
Personnel guideline (MMWR 60 No.7) for healthcare personnel was a joint initiative between ACIP and 
HICPAC. 


The National Institute for Occupational Safety and Health 


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NIOSH was established by the 1970 Occupational Safety and Health Act. This agency conducts research 
on occupational hazards, provides technical assistance and recommendations to OSHA, and participates 
in the training of occupational safety and health experts. However, its charge is based on a premise of 
determining "zero" risk of exposure, without being compelled to determine the cost/benefit of required 
interventions. Enforcement agencies such as OSHA may accept or reject recommendations from NIOSH. 
NIOSH has had a major impact on developing personal protective equipment guidance, including 
respiratory protection. 


The Agency for Toxic Substances and Disease Registry 


ATSDR is responsible for providing leadership and direction to programs and activities designed to 
protect both the public and healthcare personnel from exposures to hazardous substances. Safety 
committees are familiar with its expertise and leadership in developing emergency preparedness 
programs. A notable activity of ATSDR involved medical waste and resulted in the 1990 report to 
Congress, "The Public Health Effects of Medical Waste." The agency concluded that the general public 
is not likely to be adversely affected by medical waste generated in the traditional healthcare setting. 


The U.S. Food and Drug Administration 


The FDA develops, implements, monitors, and enforces standards for the safety, effectiveness, and 
labeling of all drugs and biologies, including food, blood and blood products, medical and radiological 
devices, antimicrobial products, and chemical germicides used in conjunction with medical devices. 

Some confusion among the agencies with overlapping jurisdictions (FDA, EPA, and OSHA) for chemicals 
was addressed through memoranda of understanding related to enforcement concerns. Historically, the 
EPA was the organization in the federal government that registered new chemical sterilants. There were 
approximately 40 formulations approved in the United States. Following the agreement between the EPA 
and FDA that sterilants and high-level disinfectants that were intended for use on medical devices would 
be the responsibility of the FDA, the FDA required all such products to be cleared by the 510(k) 
process. As a result, there are fewer formulations on the market. The FDA enforces final regulations 
governing reuse of single-use devices, leading to hospitals' almost exclusive use of third party 
reprocessing companies that must follow specific criteria from the FDA. 


• Blood safety: The FDA is responsible for the safety of the nation's blood supply. The FDA has specific 
standards for collection, testing, and distribution of blood, as well as disposal of contaminated or 
untested blood. These standards apply to all facilities that have blood banking operations and are 
being comprehensively revised. 

• Chemical germicides: The FDA regulates chemical germicides that are formulated as antiseptics, 
preservatives, or drugs to be used on or in the human body, or as preparations to be used to inhibit 


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microorganisms on the skin. Based on data voluntarily provided by the manufacturer, chemical 
germicides are divided into three categories: category I, safe and effective; category II, not safe or 
efficacious; and category III, insufficient data to categorize. Chemical germicides, when used in 
conjunction with specific medical devices, may also require FDA approval. 

• Medical Device Act (1974) and Safe Medical Device Act (SMDA) of 1990: The Medical Device Act of 
1974 required the classification of medical devices according to their potential to cause harm. The 
SMDA of 1990 expanded the FDA's authority in this area by improving incident reporting, removing 
defective or dangerous devices in a timely manner, and ensuring that only safe and effective devices 
enter the marketplace. 


The Health Resources Service Administration 


FIRSA provides leadership and support efforts to integrate health service delivery programs with the 
public and private financing programs. 


• National Practitioner Data Bank: Created as part of the Health Care Quality Improvement Act of 1986, 
the database collects and disseminates information concerning adverse actions affecting physicians, 
dentists, and other healthcare professionals. Hospitals are required to report adverse disciplinary 
actions against practitioners, query the data bank every three years, and query again at the time of 
medical staff appointment. 

• Organ Procurement: HRSA administers grant-supported programs such as operation of the Organ 
Procurement and Transplantation Network. 

• Hospital preparedness and public health infrastructure funding: In the years following 9/11, HRSA 
provided funding to states to enhance hospital and regional preparedness efforts. In 2006, the 
National Bioterrorism Hospital Preparedness Program was transferred from the HRSA to the Assistant 
Secretary for Preparedness and Response. 


Agency for Healthcare Research and Quality 


AHRQ is an agency developed by Congress to define the appropriateness or necessity of medical care. 
It was formerly known as the Agency for Healthcare Policy and Research and was reauthorized in 1999 
by the Healthcare Research and Quality Act. Its mission is to assess and enhance the quality of medical 
care through outcomes research and development of clinical practice guidelines. The role of this office 
has taken on a new dynamic with the 1999 publication of the Institute of Medicine's To Err Is Human: 
Building a Safer Health System .2 AHRQ was given the charge to coordinate all federal quality 

improvement efforts, provide health services research oversight, and lead this effort through the Quality 
Interagency Coordination Task Force. Within the new HHS-HAI Action Plan, AHQR focuses knowledge 
transfer of CDC/HICPAC-approved guidelines. 


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National Institutes of Health 


The National Institutes of Health (NIH), with its 27 specialized institutes and centers, is responsible for 
improving the health of the nation. NIH is the world's largest biomedical research organization and 
maintains the National Library of Medicine, the world's largest center of medical literature. 


Center for Medicare & Medicaid Services (Formerly, Health Care Financing Administration) 


CMS was established by HHS in 1977 and is responsible for oversight and reimbursement monitoring of 
Medicare and Medicaid programs. Its regional offices maintain close working relationships with state 
health departments for enforcement activity. 


• Infection control standards and Medicare/Medicaid: CMS maintains independent standards for 
infection prevention in hospitals, long-term care, and home care facilities/agencies and enforces 
compliance with these as conditions for certification and participation (CoP) in Medicare and Medicaid 
Programs. The Infection Control Interpretive Guidelines for each of these settings undergo periodic 
review and APIC works with CMS to provide input for hospitals, long-term acute care hospitals 
(LTACs), long-term care (LTC), ambulatory surgical centers (ASCs), and home health services. 

° Acute care: The most recent update to the CoP affecting infection prevention was the release of 
the infection control interpretive guidelines published in 2008. New emphasis is being placed on 
performance standards and outcome measurements (e.g., HAI rates). 

° LTAC: LTACs must meet Medicare's CoP for acute care hospitals and have an average inpatient 
length of stay longer than 25 days. 

o LTC: Nursing homes were required in 1998 to transmit data electronically to CMS on each patient 
in a set of assessments termed Minimum Data Set (MDS). This covers all aspects of patient care, 
including infections. LTC must now provide online "report cards" similar to the acute care "Hospital 
Compare" website to inform the consumer of their performance. In 2012, CMS released a Nursing 
Home Action Plan , which included increased focus on HAI in the survey process. 

° Ambulatory care: CMS updated in infection control interpretive guidelines for ambulatory surgical 
centers in 2009. In January 2012, CMS required dialysis facilities participating in the End-Stage 
Renal Disease Quality Incentive Program to report certain infection events to the NHSN. Linder the 
Ambulatory Surgical Center Quality Reporting program, ASCs report quality of care data for 
standardized measures to receive the full annual update to their ASC annual payment rate, 
beginning in 2014. 

° Home health services: CMS issued a final rule addressing the Home Health Prospective Payment 
System in 2013, which discusses the transition in ICD-10 coding and establishes home health 
quality reporting requirements for subsequent years. 


• Construction: Construction codes and standards for physical plant/environmental standards were 
revised with a new requirement for infection prevention input. CMS does address the physical plant in 
its CoP for the Physical Plant. However, HHS provides support to the development of design and 
construction guidelines used by most states and published by the Facility Guidelines Institute and the 


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American Society of Healthcare Engineering of the American Hospital Association. Hospital 
construction and costs are directly related to the charge of CMS's mission. Although CMS does not 
adopt the guidelines as regulations per se, the agency does concur with the recommendations. Nearly 
every state adopts the guidelines as a whole or may adapt it as a basis for their own state codes. 
CMS enforces construction codes or the guidelines through health department surveyors as agents of 
CMS for CoP in Medical and Medicaid. The guidelines have expanded requirements for a 
documented "infection control risk assessment" (ICRA). After a basic ICRA was first published by the 
American Institutes of Architects in 1996, the most recently updated version now includes many 
issues beyond the determination of needed number of airborne infection isolation rooms. The ICRA 
addresses both design and selection of materials, as well as mitigation processes during construction 
or renovation .5 

• Deemed status and state exemptions: Healthcare facilities accredited by TJC, a voluntary agency, are 
deemed to be in compliance with CMS requirements and are exempted from routine federal or state 
inspections. CMS follows and validates approximately 5 percent of accredited hospitals following a 
facility survey. State health department surveyors enforce CMS CoP in Medicare/Medicaid in facilities 
that have foregone voluntary accreditation, whether TJC, the American Osteopathic Accreditation's 
Healthcare Facilities Accreditation Program, or Det Norske Veritas Healthcare Inc. (DNV). DNV's 
accreditation program, called the National Integrated Accreditation for Healthcare Organizations 
(NIAHO), integrates the International Organization for Standards' ISO 9001 quality management 
system standards with the Medicare conditions of participation. NIAHO is the first accreditation 
program to integrate hospital accreditation with ISO 9001. 

• Medicare Quality Improvement Organizations, formerly known as State Peer Review Organizations: 
Quality improvement organizations operate under contract with CMS to ensure that medical services 
provided to Medicare patients in hospitals and certain outpatient settings are medically necessary and 
appropriate and meet recognized standards of care. Their approach has been moving from individual 
performance to that of trending and outcome measurements in line with CMS requirements. These 
organizations are key for collaborative efforts in developing and publishing public performance 
measures. 

• Clinical Laboratory Improvement Act: In 1988, Congress passed legislation (CLIA 88, 42 CFR 493) to 
amend the Clinical Laboratory Improvement Act (CLIA) of 1956. CMS issued final regulations to 
implement the statutory authority granted by CLIA, and extend the scope of CLIA to all laboratory 
testing, including physician office labs and clinics, and mandate specific personnel, proficiency testing 
quality control, patient tests, management, and computer systems. There is no umbrella organization 
coordinating the standardization of accreditation standards of all entities awarding CLIA certificates. 
States typically enforce CLIA through CMS licensing and certification divisions of state health 
departments. 

Independent Federal Agencies 

Environmental Protection Agency 

The EPA is an independent agency responsible for regulation and registration of chemical germicides 

formulated as sterilants and disinfectants used on devices or environmental surfaces as part of the 

Federal Insecticide, Fungicide, and Rodenticide Act. 

• EPA and FDA germicide responsibilities: The EPA and FDA have entered an interagency agreement 
to jointly test all registered sterilants, those products seeking registration, and those products 


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(sterilants and hospital-type disinfectants) making unsubstantiated claims about controlling 
tuberculosis. Information regarding products and their approval status is routinely available from the 
EPA's hot line, both by fax and on the Internet. 

• Resource Conservation and Recovery Act (RCRA): Through the RCRA of 1976, the EPA was 
designated the authority for developing regulation for management of solid waste, including regulated 
medical waste. To this day there is no comprehensive federal policy on medical waste. Regulations 
are driven by each state and interaction with the Department of Transportation. New attention to 
pharmaceutical waste disposal as part of general concerns on the environment may involve infection 
prevention and control programs. 

• Incinerators and medical waste: The EPA has published regulations on medical waste incinerators 
regarding emissions control and ash disposal as part of recent revisions of the Clean Air Act. 

Occupational Safety and Health Administration-U.S. Department of Labor 

OSHA is a division of the U.S. Department of Labor. Its programs are administered under the jurisdiction 
of the federal Occupational Safety and Health Act and through approved state plans. 

• General duty clause: Basic to OSHA's activity is the general duty clause of the 1970 Occupational 
Safety and Health Act requiring that an employer is responsible for providing a workplace free of 
occupational hazards. Specific standards are developed according to identified hazards, and 
compliance documents are developed to interpret the standard. State level OSHA plans may have 
additional requirements beyond the federal requirements. 

Bloodborne Pathogen Rule 

Publication of the bloodborne pathogens rule in 1991 was the first to address specifically infection- 
related activity and, in 2001, OSHA published a revision to the bloodborne pathogen standard. The new 
requirements included: an expanded definition of engineering control to include devices with engineered 
sharps injury protection and needleless systems; exposure control plans that reflect changes in 
technology that reduce exposure to bloodborne pathogens and document the consideration, at least 
annually, of devices to minimize occupational exposure; solicitation of input from nonmanagerial (i.e., 
frontline) healthcare personnel for identification, evaluation, and selection of devices and other controls 
that is documented in the exposure control plan; and maintenance of a sharps injury log of 
percutaneous injuries with information on the type and brand of device involved, the department where 
the incident occurred, and an explanation of how the injury occurred. 

Tuberculosis 

In the event that a newly identified hazard does not have an existing standard (e.g., tuberculosis [TB]), 
OSHA develops an emergency compliance document to interpret and enforce compliance under the 
general duty clause. The documents can be requested from the agency and are available on the OSHA 
website. Although a TB standard had been proposed in 1997, OSHA withdrew the proposal because it 
did not meet the criteria to justify promulgation of a standard. OSHA's revised Respiratory Protection 
Standard (29 CFR 1910.134 and 29 CFR 1926.103) went into effect in 1998. The 29 CFR 1910.139 
respirator standard that applied only to respiratory protection against Mycobacteriumtuberculosis was 
withdrawn December 31, 2003. Establishments' respiratory protection programs for TB (formerly covered 
under 29 CFR 1910.139) were required to adapt to comply with the requirements of 29 CFR 1910.134, 
effective July 2, 2004. The major change was to require annual fit testing in addition to the initial fit 
testing already under way by hospitals. OSHA resumed enforcement of this change in 2008. 


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• APIC's advocacy role: It is worth noting that APIC played an important role in several aspects of TB 
enforcement issues. APIC was successful in collaborating with many associations to provide data 
leading to the withdrawal of the TB standard as noted. APIC also led a coalition to address the lack 
of science that justified the need for annual fit testing of N95 respirators, collaborating with 
Representative Wicker to add an amendment (or rider) to the annual appropriations bill preventing 
OSHA from spending federal dollars to enforce that component of the respiratory protection standard. 
For several years the rider, aptly named the Wicker Amendment, barred OSHA from enforcing annual 
fit testing. APIC, along with more than a dozen organizations, supported reinstatement of the 
amendment because of the lack of scientific evidence that annual fit testing, an expensive mandate, 
decreased the risk of healthcare personnel exposure to TB. The U.S. House of Representatives 
Appropriations Committee rejected the amendment in the 2008 appropriation bill, reinstating OSHA's 
enforcement action for annual fit testing. 

• Compliance inspection: OSHA conducts inspections of healthcare facilities on a predetermined 
schedule, and in response to a serious hazard or as a result of an employee complaint. Recently, the 
agency has developed a targeted approach, focusing on injuries of high frequency and seriousness in 
specific industries. In those regions with state-level OSHA plans, implementation of the OSH Act may 
be under the jurisdiction of different agencies within the state. Standards and compliance with those 
standards developed within states must be at least as effective as federal OSHA. Many states adopt 
the specific federal standard by reference. 

• Occupational illness/injury logs: OSHA issues regulations to protect healthcare personnel from 
occupational illness and injury. Recent standards have addressed hazard communications (chemical 
exposure), bloodborne pathogens, and ergonomics. 

United States Department of Agriculture; Food Safety Inspection System 

The USDA has responded to increasing reports of problems of food contamination and consumer 
demand for safer food products following outbreaks of pathogens, for example, Escherichia 
coli 0157:H7, Hepatitis A, and antimicrobial-resistant microorganisms. Specific program initiatives are 
collected and managed under the program of Hazard Analysis Critical Control Points. More information 
is available from USDA Food Safety Inspection Service through its online resources. 

Department of Transportation; Research and Special Programs Administration 

Although the DOT has broad responsibility for ensuring safe transport of goods, the Research and 
Special Programs Administration (RSPA) has important linkages to regulated medical waste (RMW) and 
its transport across state lines. Although definitions and management of RMW disposal are under the 
jurisdiction of the EPA, as discussed, the DOT raised major concerns in waste management industries 
when it proposed regulations using performance-oriented packaging standards for RMW. The DOT 
promulgated its final regulation in 1996 using criteria-based definitions, and its final packaging and 
labeling requirements remain consistent with the OSHA bloodborne pathogens standard. The regulation 
allows an exemption for laboratory cultures and stocks by subjecting them to stringent packaging 
requirements. Another exemption of importance to infection preventionists is that related to transport of 
laundry and medical devices as long as procedures conform to OSHA bloodborne pathogens 
regulations. In the Federal Register of September 1998 (63; 1700), the RSPA published proposed 
further revisions to its packaging standards: "Hazardous materials: Revisions to standards for infectious 
substances and genetically modified microorganisms" (49 CFR Parts 171, 172, 178, and 183). The 
proposal considers revising the standards, including RMW, to adopt defining criteria, hazard 
communication, and packaging requirements for Division 6.2 materials consistent with international 
standards. The revision was also to revise broad exceptions for diagnostic specimens and biological 
products and improve safety and ease in understanding the regulations. Input was solicited in an 


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electronic public meeting in September 2002, and the final outcome was published for enforcement in 
February 2003. The major impact is actually on the waste hauling companies, with new requirements 
focusing on packaging. Healthcare requirements involve requirements for education of staff managing 
waste. 

CONGRESSIONAL INFORMATION AGENCIES 

Government Accounting Office 

The GAO, an agency of the legislative branch, is responsible for providing Congress with information on 
expenditures and financial management issues at the request of Congress. One report evaluated 
infection prevention and control programs in the Department of Veteran Affairs (VA) and a sample of 
non-VA hospitals. The GAO report Cost and Benefit of Needlestick Prevention (GAO-01-60R) estimated 
the cost-effectiveness of sharps with safety features. Others have assessed the government's 
bioterrorism preparedness and smallpox vaccination programs. As noted, the GAO has done several 
reports on HAI-related topics, including medical device reprocessing, HAI reporting, and coordination of 
HAI reduction efforts within the HHS. Published reports are available through the U.S. General 
Accounting Office, PO Box 6015, Gaithersburg, MD 20877 or on the GAO website. Others can be 
identified and ordered through online resources. (See Table 4-1.) 

Voluntary Accreditation Agencies 

A number of accreditation agencies have considerable effect on healthcare organizations, and the 
resulting certification has implications for both marketing and reimbursement of funding, if accreditation 
or "deemed status" is at stake. (See "CMS" section.) 

Healthcare Facility Accreditation Organizations 

The Joint Commission (TJC), formerly known as the Joint Commission on Accreditation of Healthcare 
Organizations, was established in 1915 as a hospital standard-setting program of the American College 
of Surgeons (ACS). The first hospital inspections were performed by the ACS in 1918, based on the 
ACS Minimum Standard for Hospitals. In 1951, the ACS joined with the American College of Physicians 
(ACP), the American Hospital Association (AHA), the American Medical Association (AMA), and the 
Canadian Medical Association (CMA) to form the Joint Commission on Accreditation of Hospitals (JCAH), 
an independent, not-for-profit organization whose primary purpose was to provide voluntary 
accreditation. In 1952, JCAH took over the hospital standardization program from ACS and, in 1953, it 
published the JCAH Standards for Hospital Accreditation. With the passage of the Medicare Act in 1965, 
the role of JCAH shifted, becoming more closely tied with government. The law provided that hospitals 
accredited by JCAH were "deemed" in compliance with most of the Medicare CoP for Hospitals and, 
thus, were deemed eligible to participate in the Medicare program. Currently, the ACP, the AMA, the 
AHA, the ACS, and the American Dental Association (ADA) govern TJC. 

The American Osteopathic Association provides a similar accreditation to hospitals, known as the 
Healthcare Facilities Accreditation Program. As discussed in "CMS, Deemed Status and State 
Exemptions," a third organization, Det Norske Veritas Healthcare Inc. (DNV), was approved by CMS in 
2008 to provide an accreditation program called National Integrated Accreditation for Healthcare 
Organizations. 

• Accredited organizations and TJC initiatives: A variety of healthcare organizations beyond just 
hospitals (e.g., ambulatory care clinics, long-term care, home care, laboratories) are accredited by 
TJC. Standards and scoring guidelines are published annually, and a 3-year accreditation is awarded 
to hospitals found to be in compliance. Major changes in the accreditation process began in 2003 


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under the initiative "Shared Visions—New Pathways." By 2004, organizations were doing their own 
periodic performance review midway in their review cycle, followed by the actual survey. As of 2006, 
unannounced surveys were routine. The new processes required major streamlining of standards to 
ensure each element is scorable. During this process, the Infection Control Standards were revised 
with major input from infection prevention experts. HAIs received increased attention from TJC when 
it announced that reduction of HAIs would be added as the latest NPSG for 2004 and further 
expanded in the 2009 standards. HAIs have continued to figure in a major way in current NPSG, and 
compliance relies heavily on implementation of the CDC's hand hygiene guidelines, as well as major 
infection prevention guidelines, such as catheter-associated bloodstream infections, surgical site 
infections, and prevention of multidrug-resistant organisms. 

• Indicator Measurement System (IMS): As part of its "agenda for change" during the 1990s, the TJC 
began a long-term project to develop quantitative indicators measuring certain aspects of quality 
patient care. These indicators were to have been built into the TJC's IMS, which was national and 
voluntary. However, after massive testing of the system, the IMS indicators were changed 
considerably and developed into another initiative known as ORYX. 

• ORYX and core measures: During 2003, the ORYX initiative (not an acronym but a term coined by 
the TJC for this project) began a replacement into sets of measurements termed core measures. This 
latest set of indicators is aligned with CMS initiatives overseen by state quality improvement 
organizations, as well as with AHQR measures and others proposed by organizations in the private 
sector. The intent is alignment of mandatory and voluntary quality measures and standardized 
definitions. Indicators important to infection prevention efforts, such as surgical care, pneumonia, and 
immunization, are included. 

Laboratory Inspection and Certification 

The College of American Pathologists (CAP) conducts voluntary inspections and certifications of 
laboratories. In addition, CAP performs quality control studies using research to improve laboratory 
performance. These are done every two years with laboratories carrying out self-surveys in the 
nonsurvey year. Successful surveys may provide deemed status for laboratories also accredited by TJC. 
However, TJC surveys continue to review broad laboratory performance improvement measures in which 
the laboratory interacts with the rest of its affiliated healthcare organization, beyond basic CAP quality 
control measures. The Commission on Office Laboratory Accreditation is another laboratory accrediting 
agency affecting offices and clinics and is also recognized by TJC. TJC has also entered into another 
collaborative accreditation effort with CAP and the American Proficient Institute (API) termed the Lab 
Advantage, which emphasizes a quality improvement approach. 

Other Accrediting Organizations 

Other well-known organizations accredit specific entities, such as health maintenance organizations, 
clinics, and offices, for example, National Committee on Quality Assurance (NCQA) and the American 
Medical Accreditation Programs (AMAP). Along with TJC, NCQA, AMAP, and DNV are the preeminent 
healthcare accrediting organizations. NCQA is recognized as one of the top organizations providing 
voluntary accreditation for managed care organizations—that is, health maintenance organizations 
(HMOs). HMOs primarily measure outcomes in an ambulatory care setting. NCQA has developed a 
summary of measures known as Health Plan Employer Data and Information Set (HEDIS), which is 
increasingly used as an outcomes report. HEDIS includes important preventive measures of health, for 
example, immunization rates. TJC, NCQA, and AMAP have developed a Performance Measurement 
Coordinating Council (PMCC) to ensure efficiency and consistency in their activities within these various 
organizations. Infection-related surveillance outcomes should be considered in each of these initiatives. 


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The Commission on Accreditation of Rehabilitation Facilities (CARF; www.carf.org) provides voluntary 
accreditation to facilities meeting their standards for quality in the United States, Canada, and Europe. 

State and Local Agencies 

State Agencies 

States have multiple departments that parallel functions of the federal agencies outlined here—that is, 
jurisdictions related to health, education, welfare, environment, agriculture, and so forth. The 
organizational structures vary by name and grouping of functions or programs; linkage to federal 
programs occurs frequently through funding or regulatory requirements. For example, OSHA administers 
occupational health and safety programs in many states, but at least 27 states have independent OSHA 
programs. State-plan state programs must provide enforcement that is at least as effective as that of 
OSHA. Infection preventionists should identify the agencies in their region that establish laws, rules, and 
regulations for healthcare facilities, as well as for professional licensure, certificate of need, and 
environmental regulations, such as medical waste or management of pesticides. Designated state 
agency surveyors act as agents of CMS to enforce the CoP for Medicare and Medicaid within states 
and are linked to federal agencies through regional offices. These affect healthcare service delivery 
processes and design standards for healthcare facilities, as discussed. Interaction with state and local 
agencies has become increasingly important for bioterrorism program planning as well. 

Local Jurisdiction 

Infection preventionists also need to familiarize themselves with public health and education laws 
regulated by specific state and local health departments. Regulations for reportable communicable 
diseases vary from state to state regarding what reporting is required and how reporting should take 
place. The regulations include reporting of laboratory-based infectious agents and clinical diseases and 
may also define processes for reporting outbreaks and related interventions. State-regulated healthcare 
construction codes may be influenced or modified by local authorities having jurisdiction over issues 
such as water quality, levels of discharged contaminants, and local fire marshal regulations. (See Table 
4-1.) 


Clinical Practice Guidelines 

Efforts to contain costs have heightened consumer desire for information about healthcare quality and 
value. Purchasers of healthcare demand information about providers and the care delivered compared 
to accepted clinical practice guidelines and standards. 

American College of Physicians and Practice Guidelines 

The American College of Physicians defines practice guidelines as a means of providing knowledge 
derived from a scientific analysis of the practice of medicine, in a useful format to physicians, patients, 
and others, about the best use of healthcare resources. As part of the information management and 
quality improvement, healthcare facilities integrate practice guidelines into their professional credentialing 
activities. The TJC is developing new standards requiring hospitals to consider their use when 
measuring patient care management. 

Consumer Resources 


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By the mid-1990s, more than 60 professional organizations had developed well beyond 1,500 practice 
guidelines raising concern about focus, resources, and scientific validation.3The Performance 

Measurement Coordination Council may be a start in grappling with consistency and efficiency. However, 
consumer demand and purchaser pressure for accountability related to healthcare costs led to increased 
frequency of public reporting of outcome measurements. Data began being published by facility and 
physician name in many areas of the United States by the late 1990s. These measurement "report 
cards" may ultimately lead to improved efforts of validation and better resource utilization. As noted, the 
American Hospital Association, in collaboration with other organizations, such as TJC and HHS, 
announced an initiative identifying a set of common indicators that are published as a public report card 
of all hospitals (Healthcare Quality Alliance [HQA]) similar to CMS efforts in nursing homes and home 
care. The "Hospital Compare" website ( http://www.medicare.gOv/hospitalconnpare/ 1 reports quarterly 
on all hospitals' performance and annual hospital reimbursements are dependent on hospitals reporting 
on all required indicators. In addition, many states have also passed legislation making hospital 
performance and infection prevention outcomes data publicly available. 

Professional and Trade Organizations 

Numerous healthcare professional and trade associations have influenced hospital infection prevention 
and control programs with the development of guidelines and standards on various aspects of infection 
prevention practice. Although these groups are voluntary, they often become the standard of practice for 
governmental and accreditation bodies. Several organizations have also published journals dedicated to 
hospital epidemiology and infection prevention practice to provide a forum for exchange of scientific and 
professional information. 

APIC provides published guidelines and resources, as well as online resources to inquire about or 
research existing standards and practices. The Certification Board in Infection Control and Epidemiology 
Inc. offers professional certification in infection control. APIC maintains a Practice Guidance Council 
whose members act as formal, active liaisons to multiple professional organizations with overlapping 
interests leading to joint collaborations on common issues. The breadth of interests is illustrated with a 
few examples: Association for the Advancement of Medical Instrumentation, a critical source of 
standards for sterilization practices; Association of Peri-Operative Registered Nurses; American Society 
of Testing and Materials; AHA's personal membership groups, such as the American Society of 
Healthcare Environmental Services; CDC's Healthcare Control Practices Advisory Committee 
(CDC/HICPAC); TJC; NQF; and the United States Pharmacopeia. APIC's Emergency Preparedness 
Committee interacts with many federal and state associations, and APIC's public policy and 
governmental affairs staff assist members in developing collaboration and coalition building with many 
professional groups with similar interests and alliances. 

An excellent example of this collaboration was the publication in 2008 of an important set of 
implementation strategies: A Compendium of Strategies to Prevent Healthcare-Associated Infections in 
Acute Care Hospitals. 6This series of implementation strategies was developed by the Society of 

Healthcare Epidemiology of America (SHEA) and the Infectious Disease Society of America (IDSA) in 
partnership with APIC, AHA, and TJC. The compendium was developed from the CDC's four basic HAI 
guidelines described earlier plus two epidemiologically significant organisms: MRSA and C. difficile. 
CDC/HICPAC had reviewed and provided input and worked with SHEA/IDSA to develop an 
accompanying set of practical patient guides for the consumer, built on the same guidelines. Another 
recent example of collaboration between professional organizations is the 2013 Clinical Practice 
Guidelines for Antimicrobial Prophylaxis in Surgery, developed jointly by the American Society of Health 
System Pharmacists, the Surgical Infection Society, IDSA, and SHEA. 


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International Perspective 

This chapter addresses organizations that have an impact on infection prevention and control programs 
in the United States. Infection prevention and control programs worldwide are guided by local and 
regional regulatory and accrediting groups. Additional information on region-specific regulatory bodies 
can be accessed through infection prevention and control organizations, such as the Infection 
Prevention and Control Canada (IPAC Canada), the Infection Prevention Society (IPS) in Britain, and the 
International Federation of Infection Control (IF 1C). The World Health Organization publishes healthcare 
infection prevention and control guidelines, with the goal of assisting in the assessment, planning, 
implementation, and evaluation of national infection prevention and control policies and guidelines. 

Conclusions 

Effective infection preventionists function through a variety of multidisciplinary activities within all 
healthcare delivery settings. Organizations rely on infection preventionists to understand the related 
accrediting and regulatory requirements and to recommend policy and actions based on current 
standards and guidelines. Continuous changes require IPs to remain current in the regulatory milieu to 
maintain an effective and credible program, regardless of the care setting. 


References 

[1] Haley RW, Culver DH, White JW, et al. The efficacy of infection surveillance and control programs in preventing 
nosocomial infections in US hospitals. Am J Epidemiol 1985 Feb;121(2):182-205. 

[2] Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: 
Institute of Medicine, National Academy Press, 1999:1-223. 

[3] McDonald LL, Pugliese G. Regulatory, accreditation, and professional agencies influencing infection control programs. 
In: Wenzel RP, ed. Prevention and Control of Nosocomial Infections, 3rd ed. Baltimore: Williams & Wilkins, 1997:58- 
69. 

[4] Centers for Disease Control and Prevention (CDC). Mission, Role and Pledge. CDC website. 2013. Available online 
at: http://www.cdc.gov/about/organization/mission.htm. 

[5] Facilities Guidelines Institute. 2014 Guidelines for Design and Construction of Hospitals and Outpatient Facilities. 
Dallas, TX: Facilities Guidelines Institute, 2014. 

[6] Yokoe DS, Mermel LA, Anderson DJ, et al. A compendium of strategies to prevent healthcare-associated infections 
in acute care hospitals. Infect Control Hosp Epidemiol2008 Oct;29 Suppl 1:S12-S21. 


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APIC 

XrVT OF INFECTION CONTROL 
! txv I AND EPIDEMIOLOGY 


Infection Prevention and Behavioral Interventions 


Author(s): Patricia Posa, RN, BSN, MSA, FAAN 
St Joseph Mercy Health System 

Ypsilanti, Ml 

Published: October 3, 2014 


Abstract 

As is the case with patient care treatment regimens, infection prevention processes in healthcare 
institutions are often reliant on healthcare personnels' compliance with behavioral recommendations. 

This chapter reviews the application of behavioral science theories as a guide for planning new or 
improving existing strategies to prevent the spread of healthcare-associated infection. It also suggests 
some general principles including environmental strategies to apply when developing educational 
programs and campaigns purposed to change behavior. 

Key Concepts 

• Programs to influence the human behavior aspect of infection prevention must be strategically 
planned, with reference to relevant behavioral science theories. 

• Behavioral science theory applied in infection prevention can make practitioners more efficient and 
effective by helping them focus on factors likely to be important while avoiding investment of time and 
resources into factors unlikely to be important. 

• The body of human behavior theory is very large and growing. Although theories presented in this 
chapter are only a small number of the whole, they are selected because they are widely used and 
tested in diverse settings for a range of behavioral challenges. 

• Even with sophisticated theoretical underpinnings and best practice implementation, behavior change 
theories are rarely fully successful. The current state of health promotion and behavior theory 
application is not sufficient for the complexity of most behavioral challenges, including those in 
healthcare environments. Use of theory will improve our success, not assure total victory over 
behavioral problems. 

• A focus on behavior change must be supported by organizational policies and procedures and 
environmental strategies to enhance the effect obtained by behavioral strategies implemented through 
infection prevention and control programming. 


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Background 

How could it be possible that in a society with abundant medical technology, well-trained clinicians, and 
widespread access to healthcare that a key problem in treating illness is the failure of patients to take 
prescribed medication leading to more than $100 billion dollars in unnecessary healthcare costs 
annually?iHow could it be possible that after generations of warnings from health professionals about 

one in five adults in the United States still smoke cigarettes? 2 How could it be possible that with 

widespread understanding among healthcare personnel regarding the means of transmission of 
healthcare-associated infections (HAIs), there is extensive failure to practice effective hand hygiene in 
hospitals and nursing homes?3These paradoxes illustrate the fact that our stunning progress in medical 

science and engineering has far outstripped our understanding of the dynamics of learning and human 
behavior. 

Heifetz has identified two types of challenges when implementing change: technical and adaptive. 
"Technical is defined as those that can be solved by the knowledge of the experts, whereas adaptive 
requires new learning.'^Technical work is easier than adaptive work. Yet, as the "what," it is only about 

20 percent of the change. Adaptive work, the greater percentage of transition, is the "how"—where the 
community that needs to change must engage in the process, overcome resistance, and put new 
wisdom into practice. Infection preventionists (IPs) have been far too simplistic in their approach to 
addressing the human factors of healthcare, whether the focus is on the educational component of 
patient care or advancing the adoption of best practices among healthcare personnel. 

Programming, either directed at patients or healthcare personnel, should be strategically planned. That 
is, at the very least, the planner should articulate what it is they want people (the target group) to do. 
Table 5-1 has examples of potential behavior change objectives pursued by IPs. With the starting point 
of a behavioral objective, IPs can then work backward to analyze all the factors that must be addressed 
in order for that behavior to take place in the target group. Some of the factors will be self-evident from 
tried and true clinical practice, whereas some factors are established after a thorough research effort. It 
is easy to find examples of "conventional wisdom" that turned out to be incorrect. Nevertheless, 
thoughtful and resourceful IPs can sometimes solve problems without reference to sophisticated theories 
or rigorous clinical trial and error evaluation. Courageous leaders in infection prevention will ask hard 
questions to be sure what passes for routine practice is ultimately evidence based, not just a matter of 
tradition and convenience. 

Table 5-1 Behavioral Objectives Relevant to Infection Prevention Practice 

By the end of the next six months, 80% of the hospital's staff working in general patient areas will be following hand hygiene best 
practice all or almost all of the time. 

By the end of the next six months, 95% of the hospital's staff working in surgical suites will be following hand hygiene best practice 
all or almost all of the time. 

By the end of the next six months, 95% of the hospital's staff working in intensive care (ICU/CICU/NICU) units will be following 
hand hygiene best practice all or almost all of the time. 

By the end of the next six months, 75% of the managed care organization patients directed to take antibiotics will be taking their 
medications correctly and for the proper duration. 

By the end of the next six months, 90% of clinicians will use correct gloving techniques when at risk for exposure to patient bodily 
fluids all or almost all of the time. 


Perhaps more times than not, when IPs are seeking to modify behavior among patients or healthcare 
personnel, it will not be obvious what factors should be addressed. For many years, it was not apparent 
what factors were important to help smokers quit or to support a diabetic patient's compliance to diet. 
Painful experience has taught that giving people more information about their smoking, about their 


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diabetic diet, or about their infection will often not result in desirable behavior change. In this common 
void of not being sure what will work, behavior change theory can provide a useful guide. 

Basic Principles 

In everyday experience, conversations often start with the phrase, "My theory on that is ..." followed 
only by someone's homespun hunch about the way of the world. Although this makes for stimulating talk 
between friends and coworkers, the point of discussion is not really theory in a scientific sense. 
Behavioral science theories used in health promotion are not the product of water cooler banter, but 
based on rigorous testing of components (or constructs) of a researcher's ideas. Scientific behavioral 
theories have a long gestation period, during which the research team will carefully add, subtract, and 
modify factors, always working toward a better way to predict how people will act in a given set of 
circumstances. Put another way, the researchers seek to find the most ideal circumstance composed of 
factors that will bring about the greatest change in people's behavior. 

The end result of this work is to be able to define strategies that have proven successful in facilitating 
people to adopt desirable health-related behavior (e.g., eat more fruits and vegetables) or to cease 
acting in an unhealthful way (e.g., decrease binge drinking or smoking). For example, a theory may 
define principles to motivate someone to take medication correctly. It is also important to understand 
that theory tells us, by default, what factors are not important. Theory suggests what to do and what not 
to do. Table 5-2 identifies behavioral theories widely used in health promotion and potentially helpful 
when applied to infection prevention practices. This box's list is only illustrative not exhaustive. 

Table 5-2 Behavioral Science Theories Applicable to Infection Prevention Practice 

Health Belief Model 
Social Cognitive Theory 
Transtheoretical Model 
Diffusion Theory 

Organizational Development Theory 

In-depth presentation of each of these may be found in a number of texts.4 


Healthcare personnel are seemingly hard-wired to address health education problems by giving people 
information. Telling, or giving people information, may take the form of one of a number of strategies 
including one-on-one exchanges with patients or healthcare personnel, group teaching, instructional 
materials, or electronic media. While giving information may have a role in bringing about change, it is 
rarely self-sufficient. Most IPs know this in their heart-of-hearts, but providing facts and giving 
information is often the only tool available. Yet, what might be a more effective approach? 

For guidance on this, consider a health promotion planning model called PRECEDE/PROCEED.sThis 

model shows that an educational diagnosis, which proposes that a target behavior, stated as a 
behavioral objective (see Table 5-1), may be changed by factors sorted into three categories: 
predisposing, enabling, and reinforcing. Predisposing factors are ones that will motivate people to make 
a change. Examples of predisposing factors include factual information, supportive attitudes and beliefs, 
and personal values. Although attitudes, beliefs, and values are difficult to change, the usual approach 
is to use educational and communication strategies to establish factual understanding and build attitudes 
that will help people to begin the change process. Theory provides guidance on what facts, attitudes, 
and beliefs are important (see Table 5-3). 


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Once people are motivated to begin the change process, enabling factors will capture their capacity to 
change. Capacity to change boils down to two issues: (1) do they have necessary skills and capability, 
and (2) do they have the necessary resources? For example, if the objective is for the healthcare 
personnel to use best practice gloving procedures, do they have appropriate gloves accessible when 
they need them and can they demonstrate the correct procedure for gloving? If the objective is for 
family or significant others visiting in the hospital to carry out best practice hand hygiene, do they have 
ready access to hand sanitizer and instruction? Training and coaching for skill development or by 
helping people obtain access to needed resources may improve enabling factors. 

The last category of factors that supports change is called reinforcing factors because their impact 
occurs after the target behavior has been initiated and thereby determines whether it will continue into 
the future. Reinforcement may come from the responses and interactions of team members or 
supervisors to excellent performance or it may come from observing the example of a role model, or it 
may come from patients' visceral experience (e.g., soreness when beginning an exercise program) 
consequent to the behavior. Reinforcing factors can be managed to optimize behavioral compliance. An 
example applicable to infection prevention practices is implementing hand hygiene protocols that are 
based on the assumption that healthcare personnel want to comply with safe patient care practices. 
Thus, instead of a punitive response when noncompliance to hand hygiene is observed, the organization 
using reinforcing factors would respond with strategies to motivate proper hand hygiene techniques. For 
instance, a positive approach would be "I notice that you did not use hand hygiene prior to entering the 
patient's room and I know that you want the best care for the patient. What would help to ensure your 
compliance?" The organization may in this way identify that hand sanitizers are not located for easy 
accessibility or that the dispensers are not kept properly filled or that the healthcare personnel hands 
are full of supplies prior to entering the room. Implementing reinforcing factors to sustain practice is 
about know the "how" not just the "what" of hand hygiene compliance. An organization based on 
promoting culture of patient-centered care, rewarding positive behavior, and "drilling down" or analyzing 
the processes that lead to compliance is predicted to sustain excellent performance and patient 
outcomes. 

Table 5-3 An Example of Educational Diagnosis of a Behavioral Target 

Eighty percent of outpatients will take their 
antibiotics correctly and for the entire course of the 
prescribed regimen. 


Predisposing factors • Patients will be able to summarize the benefits of taking 

antibiotics correctly, and the hazards of failing to take them 
correctly. 

• Patients will believe that their medication compliance will have 
a major impact on their recovery. 

• Nursing staff will know the consequences of exposure to 
common HAIs. 

Enabling factors • Patients have the skill and the confidence to take their 

antibiotics correctly. 

• Patients are able to fill the prescription or otherwise obtain 
their antibiotic medications. 

• Workers in clinical areas have easy access to sinks with 
antimicrobial soap and hot water. 


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Reinforcing factors • Patients' medication taking will be encouraged and supported 

by spouse or other family members. 

• Drug choice and dosage will be carefully monitored by the 
clinician to minimize side effects that will discourage 
compliance with the treatment plan. 

• Clinical staff members are rewarded when observed washing 
hands coming out of a patient room. 


This educational planning structure will make educational plans more comprehensive, increase the 
likelihood of addressing the range of critical issues determining success, and will identify logical points 
where behavioral theory can be helpful. 

REVIEW OF KEY BEHAVIORAL THEORIES 

The oldest and most widely used behavioral theory is cognitive theory. Based on abundant research and 
experiential evidence, the cognitive approach is no longer tenable.6ln brief, cognitive theory prescribes 

that the way to change health-associated behavior is to give people appropriate factual information. 

Once they know, they will respond and change appropriately. A corollary is that unhealthy behavior is 
attributed to ignorance of factual information about the behavior and its consequences. To reiterate, 
possession of some facts (not all facts) may be important for behavior change, but almost never is 
enough to sustain long-term change unless other factors are addressed. Factors that sustain change 
are addressed in the following discussion of additional theories. 

THE HEALTH BELIEF MODEL 

The health belief model (HBM) is the oldest theory specifically developed to understand and predict 
health-associated behavior. This is done by focusing on the attitudes and beliefs of individuals. The 
model was actually developed in response to the failure of a free tuberculosis (TB) health screening 
program in the 1950s. Since then, the HBM has been adapted to explore a variety of long- and short¬ 
term health behaviors, including sexual risk behaviors and the transmission of HIV/AIDS. Figure 5-1 
illustrates the constructs of HBM. 


HBM starts with the nature of beliefs in a target group regarding how serious a disease or health 
problem is and how likely they are to get the disease. The target group may consist of one person or a 
class of people, such as the employees of Hospital A. If the theory application is to a group of people, 
some assessment will be required to understand the prevailing beliefs. Whether the focus is on a single 
individual or a group, the intervention would try to narrow any gap between the actual seriousness and 
the beliefs that exist, and a gap between actual susceptibility or risk and existing beliefs about this, 
typically through education and communication methods and materials. 

This becomes more complicated when the task is to persuade staff to take precautions so that patients 
do not succumb to an HAI. In this example, healthcare personnel will have some beliefs regarding their 
own susceptibility to infection in the context of their work, but their beliefs about the susceptibility of 
patients as a result of worker actions is one step removed. While research evidence does not shed light 
on this, it might be supposed that the double motivations of self-protection and patient protection should 
be stronger together than either standing alone. 

Figure 5-1. 


The Health Belief Model.4 


View Image SI 


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Modifying factors have limited practical value. 
However, these factors play a role in 
understanding the target group's learning needs 
and might have an impact on the design of 
interventions. Modifying factors include age 
group, gender, race and ethnic group, 
socioeconomic status, rural or urban residence, 
religious affiliation, and so forth. 

Cues to action are communication messages or 
events that create heightened awareness 
regarding the need to respond in some way. 
Examples include checkup reminder cards 
received from the dentist, a caution or danger sign in the vicinity of some threat, and a serious and 
sudden life-threatening medical problem in a family member. The cue to action construct is similar to 
"teachable moment" in which a person is, by circumstances, most ready to listen and learn. Cues to 
action may have a very useful role in HAI prevention. 

With respect to behaviors presented as solutions to a threatening health problem, people will weigh the 
plusses and minuses, the pros and cons, or, in HBM terminology, the benefits minus the barriers. In 
order for a behavior change to occur, the person must anticipate some gain: better health, social 
approval, financial savings, improved functioning, pleasure, and so forth. Gains are balanced against 
barriers: factors that make the change difficult or aversive consequences. Examples of barriers include 
participation made difficult by lack of childcare, ease of washing or disinfecting hands, expense of the 
kits that include all supplies for line insertion or maintenance, weight gain as a consequence of quitting 
smoking, and the perceived relatively high cost of eating healthy foods compared to junk food. The job 
of the IP or their designee is to make sure the benefits of relevant behavior are well known, to provide 
additional benefits (e.g., incentives), and to either eliminate barriers (e.g., provide gloves that do not 
easily tear) or to empower people to overcome the barriers (e.g., skills training). 

The final construct in HBM is self-efficacy, which is the person's confidence in their ability to change and 
to sustain it long term. An example of a self-efficacy problem is the hopelessness seen in many dieters 
who have failed on a long list of diets; they begin to feel they cannot be successful. An example more 
pertinent to this discussion is the confidence among nursing staff that with all the stresses, time 
demands, and organizational chaos sometimes found in busy clinical units, they are really able to follow 
best practice hand hygiene 100 percent of the time. Promotion of self-efficacy comes by training and 
coaching in techniques, by providing supportive environments, and by periodic reinforcements. 

It is clear that HBM shows potential for applications to various infection prevention behavioral 
challenges.7 



Figure 5-2. 


Reciprocal determinism from Social Cognitive Theory.4 

SOCIAL COGNITIVE THEORY 


View Image SI 


Social cognitive theory (SCT) is built around the interaction of the person (their knowledge, 
temperament, internal motives, skills), their behavior, and the environment (physical, social, 
organizational). The interaction of the three components is called reciprocal determinism (Figure 5-2). It 


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should be noted that the factors are linked, not 
in a one-way cycle, but in a way where each 
influences the other. In other words, while it is 
intuitive that environment will influence behavior, 
the model asserts that behavior also exerts an 
influence on the environment. For example, if 
you can get a critical mass of the staff of a 
clinical unit to comply with best practice hand 
hygiene, the social environment will be 
changed, providing a tipping point to impact 
those staff members lagging behind. Likewise, 
not only does the knowledge and attitudes 
impact behavior, but behavior change can 
impact attitudes and beliefs. When state laws mandated adult use of car seat belts, many people were 
resistant. However, with extended experience in avoiding the consequences of disobeying the law, 
attitudes in the population have softened so that seat belt use has become a normal routine for most 
people, divorced from the threat of penalties. 

So what are the implications of SCT in infection prevention? To begin with, a person's motivations, 
knowledge gaps, attitudes, and skill level must be addressed. This should be done in a multiphasic way, 
using varied methods in different places and times, over a term long enough to provide repeated 
reinforcement. It will be equally important to provide an environment supportive of change. This would 
include such things as peer support, prompts from patients to professionals, role modeling by leaders in 
the healthcare environment, compliance incentives, and organizational provisions to facilitate best 
practice behavior. 

Some elements of HBM and SCT are compatible and complementary. Theory-based planning often will 
draw upon more than one theory to guide program development. 






Frceottempbcion 


I won't 


unaware, no desire, no reason 





Contemplation 


weighing change pros and cons 


Preparation 


Twill 


making plans to change behavior 


currently adopting chmge 


Figure 5-3. 

Transtheoretical Model or Stage Theory; 

View Image 

TRANSTHEORETICAL MODEL OR 
STAGE THEORY 

The principal concept behind stage theory is 
readiness. For any given health-associated 
behavior, people will have diverse orientations 
to change. Some will be unaware that a 

particular change is a desirable option, whereas others have already completed the change but are at 
risk of reversing their progress or relapsing. The corollary to the recognition that people can be 
categorized by different levels of change readiness is that the methods applied to different levels of 
readiness will not be the same. For example, the infection prevention practices needed by a newly 
employed environmental services worker will be addressed in a way very different from providing 
refresher training to an experienced medical technologist. See Figure 5-3 for an illustration of 
transtheoretical model (TTM). 


change made, avoiding relapse 


In the healthcare environment of a large institution, healthcare personnel will be at all levels of 
readiness to change as outlined by TTM. Perhaps the major group, the clinical professionals with 


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advanced degrees and training, will be in the maintenance stage of readiness with a history of applying 
infection prevention techniques. Yet, because of the lack of reinforcement or expectation of the 
organization, they are at risk for relapse to substandard practices. Stage theory provides the IP with 
concepts to tailor intervention approaches to the readiness-related learning needs of the various 
subgroups of the workforce. 


PrecootMrpbcion group 
“7 won't" 


Coot r orpin ion group 
“7 might" 


Preparation grtxg) 

~I Will- 


Action group 

*1 am" 


Maintenance 

'I fwve" 


Mixed comnunKJtiortt to highlight the problem of 
infection spread in health care seeing 


Commune cations and role modeling to show 
advantages, minima* disadvantages of beet practice 


Identify resources, provide training for best practice 
tecbnicfiu 


Figure 5-4. 

Stage theory applications to hand hygiene 
promotion. 

View Image 

Having healthcare personnel complete brief 
questionnaires designed to assess perceptions 
and practices regarding a recommended action, 
such as hand hygiene, can be used to tailor the 
educational approach to meet the level of 
stage-based readiness. In addition, groups 
composed of different categories of healthcare 
personnel may be gathered into focus groups 
and interviewed to establish stage of readiness. 

Educational strategies are adapted accordingly in addressing the needs of each of these groups. See 
Figure 5-4 for an illustration of strategies tailored to each level of the TTM. 


Coaching, training, reinforce self- efficacy to master 
best practices, provide social reinforcement 


Continued reinforcement, peer support, highlighting 
best practice compliance in small group settings 


POSITIVE DEVIANCE 

Positive deviance (PD) is a behavioral change approach that is based on the observation that in any 
community there exists individuals who have found uncommon practices and behaviors that enable them 
to achieve better results than their peers, despite the similarities of problems and available resources.8 

This theory is grounded in the assumption that in every community there are untapped assets or 
resources. With the PD approach, sustainable behavioral and social change can be achieved through 
identification of solutions that already exist within a system. PD design consists of four steps: define, 
determine, discover, and design.8 


This process has been successfully applied to infection prevention and other health-related problems.8,9, 

loThe Pittsburgh VA hospital reduced the incidence of methicillin-resistant Staphylococcus aureus by 

more than 50 percent in a year and a half using PD.sMultiple hospitals, using PD, were able to 

significantly increase compliance with hand hygiene.8,loOne of the key principles of PD is that the 

community must own the entire process. They must discover the uncommon successful behaviors and 
design ways to expand them into common practices that are used consistently monitoring their own 
progress. 

GENERAL CONCEPTS DRAWN FROM LEARNING AND BEHAVIORAL 
SCIENCE THEORIESs 

In addition to the formal theories discussed, there are some general principles that should be 
considered when planning and implementing education and communication campaigns for patients, 
family members, or healthcare personnel. The following list of items provides some guidance to enhance 
program planning: 


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1. Include representatives of the target group into your planning. Not only does this promote 
ownership and responsibility, but it also can also provide insight into what might be more effective 
educational strategy. 

2. If the target group has a lot of cultural diversity, it will be important to secure planning input from 
groups not in the cultural mainstream of the target group. 

3. Repetition of concepts over time and with various instructional or communication tools will enhance 
learning. 

4. As much as possible, employ active learning strategies as opposed to just relying on passive, one¬ 
way dissemination of information. 

5. Encouragement and recognition of mastery enhance learning. Learners need to know that they 
understand, are meeting expectations, and have strengthened their competency. 

6. Multisensory learning is more effective. In developing instructional and communication strategies, 
try to use visual, auditory, and, as appropriate, the senses of taste, touch, and smell. 7 

Learners come with various levels of motivation, vocabulary and health literacy, existing habits and 
conceptions, and life experiences. Thus, an education program has to balance the efficiency of group 
instruction and communication against the limits of effectiveness that are a function of diverse learning 
needs in a group. 

ENVIRONMENTAL STRATEGIES 

Experience has taught that education and communications must be supported by circumstances that 
facilitate action. For example, the success of seat belt education was greatly enhanced when seat belt 
use became mandatory. The success of youth tobacco education was increased by policies making 
cigarettes more expensive. Efforts to encourage employees to be more physically active can have 
greater impact, for example, by designing company stairways that are attractive and inviting. 

Conclusions 

The lesson for IPs is that they should work with frontline staff to improve infection prevention practices 
through application of theory-based tools and processes to create sustainable change. They must also 
build in environmental strategies to make best practices easier to do. Examples of this include the 
number and placement of sinks and hand sanitizers, the easy availability of gloves and supplies needed 
for standard and transmission-based precautions, active involvement and encouragement by institutional 
leaders so that a safety-oriented climate is reinforced and sustained, use of soaps and sanitizers that 
are less irritating to skin, use of touchless faucets and towel dispensers, devices to monitor the 
frequency and duration of handwashing, and automated electronic prompts to remind staff to perform 
hand hygiene. 

This combination of theory-based education, communications, and environmental approaches, including 
both physical and organizational circumstances, will greatly enhance the success of infection prevention 
processes reliant on behavior change. 

Future Trends 

Infection prevention is at the interface between clinical care and public health. Clinical care tends to be 
oriented to one case at a time with an individual assessment-driven plan of care. On the other hand, 
public health assesses and intervenes with entire communities or target groups. To be most successful, 


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infection prevention must address clinical problems from a public health or systems approach. The 
supplemental reading at the end of the chapter reviews some of the published research on behavioral 
interventions in infection prevention. However, we are a long way from a finished evidence base. Much 
more research along those lines is waiting to be done. While numerous theories have been applied to 
behavior problems in infection prevention, there are many other theories that have not yet been tested 
in the infection prevention arena. Furthermore, theory researchers will undoubtedly demonstrate the 
validity of new theories with relevance in the future 

In addition, the evidence on effective public and institutional policies that provide environmental supports 
for infection prevention is still in its infancy. Furthermore, there are new technological tools that provide 
solutions but also present new behavioral challenges. Finally, we must understand how infection 
prevention practice in tertiary care medical institutions translates to different settings of care and other 
community sites, such as athletic facilities and jails, where infections increasingly occur. This research 
agenda goes far out into the horizon and will occupy young researchers perhaps for the better part of 
their careers. Because of the very threatening rise in incidence of some of the most serious HAIs, these 
research questions must be supported and pursued. 

International Perspective 

Infection prevention is a concern in healthcare in every corner of the globe. Because of the ease of 
international movement of people in the 21st century, there is the prospect of the homogenization of the 
microbial climate, requiring the same prevention efforts everywhere. We have not really seen this in full 
bloom, but instead tremendous diversity, even just within the United States, in the incidence of HAIs. 

Nevertheless, infection prevention is required everywhere. It is fair to ask whether policies and 
procedures considered best practice in Western medical facilities are relevant and feasible in non- 
Western cultures, often with limited resources. It is also fair to ask whether behavioral theories, largely 
developed through research in Western populations, translates well to other cultures. Even in the United 
States, the recognized behavioral theories, such as those summarized in this chapter, do not necessarily 
explain and predict behavior perfectly. For example, we could use the HBM to design a campaign 
promoting human papillomavirus vaccination. However, some individuals and groups will have moral 
values related to use of the vaccine that will trump the HBM constructs. This risk becomes even more of 
a concern the further we are from psychosocial dynamics considered normal in mainstream Western 
culture. This does not mean that the theories are useless, but that it becomes even more critical to 
include members of program target groups into early planning so that you have "on-the-ground" 
perspectives of what might or might not be effective in a particular culture or geographic area. 

The application of behavioral theories as tools to guide development of infection prevention and control 
programs is still fairly new, even in advanced nations and communities. This is even more the case in 
disadvantaged parts of the world. Whenever our understanding of best practice and the evidence base 
for interventions is deficient, which it clearly is in infection prevention, the critical need for rigorous 
evaluation is highlighted. We must determine what works and what does not work, disseminating our 
findings so that the knowledge base from intervention in the developed and the developing world are 
made available to all infection preventionists. 

Supplemental Resources 


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American Academy of Pediatrics Respiratory Syncytial Virus Policy. Available at: Borghesi A, Stronati M. 
Strategies for the prevention of hospital-acquired infections in the neonatal intensive care unit. J Hosp 
/nfecf2008;68:293-300. 

Mah MW, Tam YC, Deshpande S. Social marketing analysis of 2 years of hand hygiene promotion. 

Infect Control Hosp Epidemiol2008 m ,29.262-270. 

On the CUSP: Stop HAI, sponsored by Agency for Healthcare Research and Quality (AHRQ). 2013. 
Available at http://www.onthecuspstophai.ora/on-the-cuspstop-cauti/toolkits-and-resources/ . 

Pessoa-Silva CL, Hugonnet S, Pfister R, et al. Reduction of health care associated infection risk in 
neonates by successful hand hygiene promotion. Pec//afr/cs2007;120:e382-e390. 

Pittet D. The Lowbury lecture: Behavior in infection control. J Hosp /nfecf2004;58:1-13. 

Pyrek KM. Handwashing and cross contamination: Old issue, new approaches. Infection Control 
Toc/ayMarch, 2004. 

Sax H, Allegranzi B, Uckay I, et al. "My five moments for hand hygiene": a user-centered design 
approach to understand, train, monitor and report hand hygiene. J Hosp /nfec/2007;67:9-21. 

Sax H, Uckay I, Richet H, et al. Determinants of good adherence to hand hygiene among healthcare 
workers who have extensive exposure to hand hygiene campaigns. Infect Control Hosp 
Epidemiol2007 ;28:1267-1274. 

Whitby M, Pessoa-Silva CL, McLaws ML, et al. Behavioral considerations for hand hygiene practices: the 
basic building blocks. J Hosp /nfec/2007;65:1-8. 

References 

[1] Viswanathan M, Golin CE, Jones CD, et al. Interventions to improve adherence to self-administered medications for 
chronic diseases in the United States: a systematic review. Ann Intern /Wed2012 Dec 4; 157( 11 ):785—795. 

[2] Centers for Disease Control and Prevention (CDC). Adult Smoking in the US. CDC website. 2011. Available at: 

http://www.cdc.qov/VitalSiqns/AdultSmokinq/index.html#Statelnfo . 

[3] Erasmus V, Daha TJ, Brug H, et al. Systematic review of studies on compliance with hand hygiene guidelines in 
hospital care. Infect Control Hosp EpidemioPOVf) March;31(3):283-294. 

[4] PB Works. Perspectives on Change: Ronald A. Heifetz. PB Works website. 2007. Available at: 

http://chanqetheorists.pbworks.eom/w/paqe/15475038/Ron%20Heifetz . 

[5] Glanz K, Rimer BK, Viswanath K. Health Behavior and Health Education: Theory, Research, and Practice, 4th ed. 

San Francisco: Jossey-Bass, 2008. 

[6] Larson E, Kretzer EK. Compliance with handwashing and barrier precautions. J Hosp Infect 1995 Jun;30 Suppl:88- 
106. 

[7] Zomer TP, Erasmus V, van Empelen P, et al. Sociocognitive determinants of observed and self-reported compliance 
to and hygiene guidelines in child day care centers. Am J Infect Control 2013 Oct;41(10):862-867. 

[8] Pascale RT, Sternin J, Sternin M. The Power of Positive Deviance: How Unlikely Innovators Solve the World's 
Toughest Problems. Boston: Harvard Business Review Press, 2010. 


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[9] Macedo Rde C, Jacob EM, Silva VP, et al. Positive deviance: using a nurse call system to evaluate hand hygiene 
practices. Am J Infect Control20'\2 Dec;40(10):946-950. 

[10] Mara AR, Noritomi DT, Westheimer Cavalcante AJ, et al. A multicenter study using positive deviance for improving 
hand hygiene compliance. Am J Infect Confro/2013 Nov;14(11):984-988. 


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APIC 

XrVT OF INFECTION CONTROL 
i txV I AND EPIDEMIOLOGY 


Healthcare Informatics and Information Technology 


Author(s): Sara Bienvenu, RN, MSN 

Clinical Manager, Infection Prevention 

Clinical Services Group 

HCA Hospital Corporation of America 

Nashville, TN 

Julia Moody, MS SM(ASCP) 

Clinical Director, Infection Prevention 

Clinical Services Group 

HCA Hospital Corporation of America 

Nashville, TN 

Published: October 3, 2014 


Abstract 

Reducing the risk and occurrence of infections is the result of an effective infection prevention and 
epidemiology program. Healthcare informatics and information technology provide a means by which 
evidence-based care bundles and infection prevention data can be effectively collected, stored, 
analyzed, and reported from documentation in the electronic healthcare record. The role of technology 
in infection prevention and control has increased due to regulatory requirements and the desire to 
secure patient health information. Healthcare informatics is a powerful tool to support infection 
preventionists to drive high compliance with evidence-based care bundles and in meeting requirements 
set forth for data availability and public reporting. 

Key Concepts 

• Information technology resources and processes are used to retrieve, distribute, and store packets of 
information to aid infection preventionists in effectively performing infection prevention-related tasks. 

• Databases can speed and simplify the collection, management, and communication of information 
needed for infection prevention and treatment, surveillance, outbreak detection/investigation, 
education, and more. 


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• Information security requires safeguards to protect patient health information. 

• Informatics is the process of applying computer technology to the scientific process. Informatics has 
improved the tools available to health, medical, and nursing professionals. 

• Healthcare informatics and information technology foster quality improvement by enabling the use of 
evidence to monitor and improve processes and outcomes. 

• Healthcare informatics and information technology support accurate, efficient extraction and upload of 
publicly reported infection data cases and data. 

• Syndromic surveillance focuses on the detection of emerging infectious diseases and agents of 
bioterrorism. 

• Mobile computing devices affect practice at the point of care by providing improved access to patient 
and diagnostic information, and have expanded to include mobile physicians via robotic design. 

• Digital connectivity allows for greater clarity and accessibility, particularly with radiographic imaging, 
and promotes secure access such as digital certificates. 

• Information technology will continue to advance toward increased capacity in smaller and more mobile 
devices as well as increased sharing of information across broader networks. 

Background 

Information technology (IT) plays a pivotal role in the duties and responsibilities of infection 
preventionists (IPs). The IT structures of most healthcare institutions have undergone significant 
changes to meet the challenges set forth by complex data demands and health IT governmental 
regulations. 

Healthcare and nursing informatics have transformed data collection from a manual data process to an 
automated electronic one. Yet, there are still opportunities to maximize the effectiveness of these tools. 
IPs spend a substantial amount of time utilizing systems for collecting, processing, storing, analyzing, 
reporting, and disseminating critical data. IPs are knowledge professionals, and therefore must be able 
to efficiently and effectively use the most current technologies available and embrace the systems used 
within their healthcare setting. This chapter reviews how IT affects and interacts with the practice of 
infection prevention and offers a primer on basic technologies and methods. 

Basic Principles 

HEALTHCARE INFORMATICS AND NURSING INFORMATICS 

Informatics is the study of information processing with the purpose to translate knowledge into practice. 
Healthcare informatics is the science of using information technology to design, develop, apply, manage, 
organize, analyze, and optimize healthcare delivery with the goal to improve patient care processes .1 

Tools include clinical guidelines, IT systems, and electronic devices. Foundational information technology 
terms and concepts are described in Appendix A (at the end of this chapter). Nursing informatics 
enhances the documentation accuracy and enables data analysis of nursing practice .2 

HIPAA, SECURITY, AND INTERNET SAFETY 


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Title II of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) sets privacy standards 
and security standards for protected health information (PHI). Since its implementation, HIPAA has 
changed the way healthcare facilities collect and handle certain patient information, particularly to 
ensure the confidentiality of PHI at every stage. Changes in the law also have alerted the general public 
to the ways in which their personal health data are managed and disclosed to providers, healthcare 
entities, insurers, and data clearinghouses. 

Healthcare providers must conduct a review of their data collection and entry practices and create 
policies that address: 

• Data security 

• Data privacy 

• Data disclosure 

• Notice of policies and procedures 

• The expectation and practices of business associates 

• Consent to disclose data 

• Usage of research data 

PHI is vulnerable to security breaches at several junctures. One is during the collection of data using 
portable, handheld, or wireless devices. Sensitive and confidential data may be vulnerable if such 
devices are lost, stolen, or left unattended. The use of passwords, encryption, and timed sign-off 
screens can make such devices more secure. 

Security breaches also are possible in the infection prevention and control department during mandatory 
reporting of communicable diseases to local and state public health departments and the Centers for 
Disease Control and Prevention (CDC). When transmitting protected health information, IPs must ensure 
patients' privacy by using secure facsimile machines and facsimile cover sheets that instruct the 
recipient what to do if the information is reported in error or is incomplete. 

The security of email and Internet communications is usually regulated at the facility or corporate level 
(i.e., by the IT department). However, IPs must be vigilant against accidentally including sensitive 
information in material that is copied or forwarded to multiple recipients or electronic lists. Highly 
sensitive data can be protected with the use of encryption and verification tools such as digital 
signatures, passwords, key codes, or digital certificates. 

REGULATORY-BASED SURVEILLANCE 

The Role of Public Healthcare-associated Infection Reporting and Prevention 
The prevention of healthcare-associated infections (HAIs) is now a very public issue in response to 
evidence that HAIs are largely preventable and that HAI deaths rank among the highest causes of 
deaths in the United States. In 2009, the National Action Plan to Prevent Health Care-Associated 
Infections: Road Map to Elimination (HAI Action Plan) was developed by the U.S. Department of Health 
and Human Services (HHS).3lnitially, the reduction of HAI rates targeted acute care hospitals; however, 

the scope of the action plan has expanded over past years to include additional healthcare settings in 
the nonacute and ambulatory setting. Acute care targets include: central line-associated bloodstream 
infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), surgical site infections (SSIs), 


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methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile (C. difficile), and influenza 
vaccination among healthcare personnel.3 

In response to the American Recovery and Reinvestment Act of 2009 (RL. 111-5), all states developed 
HAI Action Plans consistent with the National HAI Action Plan. In addition, since 2003, 30 states have 
enacted HAI reporting laws.4 

In compliance with the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148), the Centers 
for Medicare & Medicaid Services (CMS) Hospital Inpatient Quality Reporting (IQR) Program added HAI 
measures effective with the federal fiscal year 2013 payment determination period. Hospitals receiving 
Medicare reimbursement must enroll, complete National Healthcare Safety Network (NHSN) training, and 
submit HAI data to NHSN in order to comply. Nonparticipation or noncompliance will result in a reduction 
to the hospital's annual market basket update, with the percentage of the reduction determined each 
year by CMS.sAnnually, CMS performs validation of HAI measures on randomly selected and targeted 

participating hospitals.6Hospitals chosen for validation are required to use validation templates to submit 

patient lists from specified locations that include specified pathogens (from cultures or nucleic acid 
amplification testing) as defined by CMS rules for validation of HAI reporting measures in NHSN—for 
example, positive urine and blood cultures for validation of CLABSI and CAUTI reporting in NHSN. 

HAI reporting measures are published by CMS on the Hospital Compare website 
( http://www.medicare.qov/hospitalcompare/search.html ) to allow consumers to make informed 
decisions regarding their healthcare choices. 

NHSN Reporting and CMS Data Validation 

The CDC collects HAI measure data via the NHSN application and uses these datasets to track and 
trend national HAI data. This secure application is used by U.S. hospitals for voluntary reporting of 
internal HAI tracking as well as to meet public reporting requirements for states and the CMS IQR 
program. 

NHSN Reporting 

There are four methods that can be utilized to enter reporting data into NHSN: manual entry (direct 
entry of reporting data into NHSN reporting modules); electronic imports via ASCII comma delimited text 
files, also known as comma separated value (CSV); electronic imports via clinical document architecture 
(CDA); and automated send NwHIN Direct, also known as batch submission, via CDA. 

It is important to note that electronic imports (CSV and CDA files) and automated send NwHIN Direct 
can only be used to upload reporting datasets that NHSN has made acceptable to the NHSN application 
(see the CDC National Healthcare Safety Network website for more information). 

Manual Entry 

All HAI measure data can be manually entered into NHSN by directly entering reporting elements into 
each field of the applicable NHSN reporting module. This manual methodology allows all facilities to 
have a means of complying with public reporting compliance. Traditionally, data elements for manual 
entry are sourced by the IP during surveillance. The IP may access required reporting data via manual 
review of paper and electronic medical records and/or retrieve needed reporting data for analysis via 
reports in the electronic health record (EHR) or other external databases. Due to increasing HAI 


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reporting requirements, many hospitals are utilizing electronic reporting options to decrease the clerical 
burden of public reporting. 

Electronic Methods 

NHSN is committed to providing electronic reporting options that may be used to streamline reporting 
into the NHSN application. Facilities may choose to leverage technology to capture reporting elements 
from their EHR or other external databases. The method chosen is often driven by the accessibility of 
needed data elements and the resources available at the organization, such as the technological skills 
to build or the capital to develop or purchase software for this purpose. 

Sourcing Data for Electronic Reporting 

The extraction of clinical data from the EHR requires, at minimum, a semistructured EHR that has 
standardized entry of clinical data in order to allow for data to be located for extraction.7l_aboratory, 

medication administration, diagnostic data, and admission, discharge, and transfer (ADT) data may be 
sourced from different electronic sources housing medical information. Clinical data elements such as 
lines and device insertion/discontinuation and vital signs can only become useful for electronic data 
capture when documentation entry is standardized to a defined location in the EHR .7 

ASCII Comma Delimited Files 

Electronic importing options available in NHSN include the importation of ASCII comma delimited text 
files, also known as CSV, which are used to package reporting data in the required order and format 
defined by NHSN. Facilities may have an opportunity to capture all or a portion of the required reporting 
elements from the EHR into a CSV file.8 ,9 

The electronic data captured in the CSV file can be viewed by the IP in a spreadsheet format which 
gives the IP the opportunity to validate and revise data fields as needed, as well as add any missing 
data elements that could not be extracted from the EHR. This electronic reporting method is the least 
complex NHSN electronic reporting option but may only be used to import those reporting measures that 
have been provided as an option in the NHSN application. Reporting data housed in CSV files need to 
be manually imported into a facility's NHSN reporting application. 

Clinical Document Architecture 

CDA file development is complex and typically implemented through vendor software. HHS published a 
set of Health Level 7 (HL7) standards in the Final Rule of Health Information Technology.ioHL7 codes 

are standardized message codes that allow information to be packaged and communicated from one 
system to another. Because HL7 codes are used universally from one EHR system to the next, data 
packaged within HL7 codes can be captured and used for creating CDA files. For example, ADT, 
microbiology and lab reports, radiology reports, dictated reports, and pharmacy data are typically 
packaged in HL7s. 

CDA files allow for more robust NHSN electronic reporting options than CSV files, including event 
reporting (SSI, CLABSI, CAUTI, and laboratory identified event) and reporting of device aggregates for 
summary data. Infection prevention surveillance systems are designed to capture the needed datasets 
for reporting from the infection classification documentation entered in the system by the IP. NHSN 
reporting data can then be exported into a CDA file that meets NHSN CDA specifications. During this 
process most systems will also analyze the data being exported to the CDA file and alert the IP to any 


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errors that would preclude acceptance to NHSN. CDA files are imported manually by the facility into the 
NHSN application. 

Automated Send NwHIN Direct 

Automated Send NwHIN Direct, also known as batch submission, automates submission of reporting 
data into NHSN. CDA files containing the reporting data from one or more facilities are compressed, 
pushed to NHSN, and incorporated into a facility's NHSN reporting application. The direct messages 
generated by the source, typically an infection prevention surveillance system, package the reporting 
data to conform to direct-prescribed message structure.6 

Reporting Integrity 

Electronic reporting requires validation of data by the facility prior to import or automated submission to 
NHSN to ensure that the information provided is accurate and complete. In addition, submitters are 
expected to review data imported to NHSN to validate the submission.n 

Additional Reporting Steps 

Facilities that submit reporting data electronically to NHSN will still be required to access NHSN and 
manually perform required reporting steps to complete NHSN reporting, such as monthly reporting plans, 
annual surveys, and maintaining reporting locations mapping. In addition, manual entry of some 
reporting elements may be required if available as an option for electronic reporting in NHSN. 

CMS Data Validation 

Hospitals selected for HAI measures validation are required to use CMS validation templates to submit 
patient lists from specified locations that include specified pathogens (from cultures or nucleic acid 
amplification testing) as defined by CMS rules for validation of HAI reporting measures in NHSN—for 
example, positive urine and blood cultures for validation of CLABSI and CAUTI reporting in NHSN .12 

Specified criteria for identification of qualifying labs must be applied and the data must be reported in 
the format and order defined within the validation templates. Hospitals may choose to leverage 
electronic technology to identify cases and extract required reporting elements, in the format and order 
required, from medical information sources. Data may be captured in an excel file or CSV file, reviewed 
for accuracy and completeness, and then transferred (i.e., copied and pasted) onto the required CMS 
validation template for submission. 

QUALITY IMPROVEMENT AND INFORMATION TECHNOLOGY 

In healthcare, the focus is on patient care and patient safety. IT can foster creative methods for 
monitoring and improving quality, performance, and infection prevention, as noted in Figure 6-1. For 
instance, The Joint Commission defines the seventh national patient safety goal as reducing the risk for 
HAIs, which is directly related to infection prevention. This goal is evidenced by two components: (1) 
compliance with the CDC's hand hygiene guidelines, and (2) managing all cases of HAI that result in 
unanticipated death or major permanent loss of function as sentinel events. For many healthcare 
providers, meeting this goal requires computerized monitoring of patient outcomes, sources of infection, 
and staff compliance with hand hygiene training and practice. The Joint Commission set forth those 
safety initiatives; CMS set forth the ninth scope of work. The ninth scope of work stipulates the 
nonpayment of certain HAIs (e.g., urinary tract infections and bloodstream infections). As this process 


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continues to emerge, the need for computerized data to facilitate accurate, efficient data submission for 
public reporting of infections is now more evident than ever before. 

Figure 6-1. 


Optimizing Performance Improvement With 
Information Technology 


Dat3 Transmission 



| Pat3 I 



Health Care 
Informatics 


Performance 

Improvement 


Information 

Technology 


Optimizing performance improvement with 
information. 

View Image 

EMERGING INFECTIOUS 
DISEASES AND SYNDROMIC 
SURVEILLANCE PROCESSES 


information 


Transfer of Information 



a 


As technology changes, so does the role of the 
IP. Technology is necessary for the task of 
syndromic surveillance, a continuing challenge 
for infection prevention departments, agencies, 
and centers in the face of a threat of 
bioterrorism and national or global disease 
outbreaks or epidemics. In the wake of threats 

such as anthrax, severe acute respiratory syndrome (SARS), monkeypox, avian and swine influenza, 
and Middle East respiratory syndrome coronavirus, IPs must implement bioterrorism preparedness 
initiatives and conduct syndromic surveillance to identify and curtail the spread of disease in a 
population. Emergency preparedness efforts must focus on handling influxes of patients with confirmed 
or suspected exposure to a novel or rapidly transmissible disease. Advanced knowledge of a situation 
such as this is paramount to facilitate preparation efforts; thus, surveillance should encompass a wide 
variety of healthcare data. Syndromic surveillance is designed to accomplish this task. Syndromic 
surveillance is conducted on a very large scale, combining data from multiple sites or geographical 
areas. Surveillance of this magnitude requires highly technical, adaptive, and powerful systems that can 
import data from multiple sources and use a form of data mining to generate alerts when unusual 
clusters of syndromes are identified. 13 


The state of Florida established the ESSENCE system for emergency departments (ED) and urgent care 
centers in 2007 .mAs of 2011, approximately 85 percent of emergency visits are monitored by ESSENCE 

via daily electronic transmission of an electronic record in a standard format for every ED visit in 
participating hospitals. Records are electronically extracted from the healthcare information system, 
requiring no manual entries, including age, sex, zip code, date, time, and chief complaint. ESSENCE 
searches for key words in the chief complaint and assigns each record to one or more syndromes. 
Discharge diagnoses are sent with follow-up record transmissions. 

Healthcare informatics can be leveraged to perform syndromic surveillance performed at the local facility 
level to detect sudden spikes with inpatient admissions. An example of screening patients for acute 
respiratory infections is shown in Figure 6-2. 

MEANINGFUL USE AND TECHNOLOGY 

A report first published in 2001 by the Committee on the Quality of Health Care in America (a 
committee within the Institute of Medicine) specifically recommended the use of IT to improve access to 
information and support evidence-based decision making, is It recommended a national commitment to 

building an information infrastructure to support healthcare delivery, consumer health, quality 


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measurement and improvement, public accountability, clinical and health services research, and clinical 
education. 

Many healthcare facilities use data networks to consolidate clinical laboratories, share patient health 
data among providers, allow physicians to review and sign a multitude of orders for patient care, 
facilitate communication among consulting physicians, and more. Implementation of risk management 
strategies helps maximize protection of patient health information. The Patient Protection and Affordable 
Care Act (PPACA) is a federal statue signed into law in 2010 preserving patient privacy and 
confidentiality and has impacted healthcare and nursing informatics. 

On February 17, 2009, the American Recovery and Reinvestment Act (ARRA) was signed into law. As 
part of ARRA, the Health Information Technology for Economic and Clinical Health Act (HITECH) 
established incentives for the "meaningful use" of certified EHR technology. Over $27 billion in incentive 
payments have been made available to help promote and encourage the use of health information 
technology (HIT) in a "meaningful manner." Meaningful use Stage 1 incentives ended in 2012 and Stage 
2 incentives began in 2013.16 i7The new HITECH environment has been transformative, enabling 

healthcare professionals to have access to electronic data, feedback on performance measured by 
evidence, and continuous monitoring at the point of care. 

Figure 6-2. 

Sample electronic screening for acute 

respiratory infections at the point of patient 

entry (courtesy of Julia A. Mood . 

View Image 1^1 

HITECH incentives are only available to those 
eligible professionals (EPs) and hospitals that 
successfully implement, utilize, and attest to 
using EHRs as defined by a series of final rules 
developed specifically for each stage of the 
program. It is important to note that attestation for meaningful use is "all or nothing" in terms of 
approach. Therefore, hospitals must meet and achieve all of the requirements and thresholds as defined 
in each stage in order to attest and receive the HITECH incentive payments. 

Starting in 2015, CMS will begin to apply payment adjustments (i.e., penalties) to providers who do not 
participate in the EHR incentive program.i6The payment adjustment is applied annually if the provider 

does not meet meaningful use requirements, with a maximum adjustment after 2018. 

Meaningful use strives to address national health policy goals. These five goals are to improve quality, 
safety, and efficiency and reduce health disparities; engage patients and their families in their care; 
improve care coordination; improve population and public health; and ensure adequate privacy and 
security protections for personal health information 

HOW IS "MEANINGFUL USE" DEFINED? 

Meaningful use is defined by meeting three stages of progressively more rigorous requirements 
established by CMS. Each stage includes specific requirements for core and menu set objectives, 
measures, and EHR certification standards that must also be achieved. 

Essentially, EHRs are digital versions of patients' paper charts and provide real-time, patient-centered 
records. They make information available instantly, "whenever and wherever it is needed" to authorized 



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healthcare professionals. EHRs bring together, in one place, everything about a patient's health. The 
regulatory requirements of meaningful use have helped to provide a powerful framework for the 
healthcare industry and have accelerated the transition from paper-based documentation to EHRs. 

THREE STAGES OF MEANINGFUL USE 

Stage 1 requires hospitals to implement and use certified EHR technology to demonstrate 14 core 
criteria functions, and to select and fulfill 5 out of 10 criteria from a "menu" of possible options and 15 
clinical quality measures. This stage of the program formed the framework for data capture and sharing. 
The last year to begin participation in the EHR incentive program (i.e., start Stage 1) is 2014. All 
providers must participate and achieve meaningful use under the Stage 1 criteria prior to transitioning to 
Stage 2. 

The Stage 2 Final Rule was published on September 4, 2012, and seeks to build on the Stage 1 
foundation while advancing clinical processes, interoperability, and increasing patient engagement. 

Shared access to electronic health information between providers and patients can foster collaboration 
in managing and treating chronic health conditions such as asthma, diabetes, and obesity. 

Interoperability leads to improved care coordination between providers and care teams, especially during 
transitions of care, thus reducing the fragmentation of patient care. 

Although the specific requirements and final measures for the third phase of meaningful use have not 
been published, Stage 3 will focus on improving outcomes and overall population health. 

WHAT ARE THE MEANINGFUL USE CORE OBJECTIVES? 

Meaningful use core objectives can be leveraged to support surveillance activities. Healthcare facilities 
can select meaningful use objectives for a best fit. Core objectives include: 

• Computerized physician order entry (CPOE) to standardize evidence-based care (e.g., influenza 
immunizations, ventilator care bundles) 

• Patient demographics 

• Vital signs 

• Clinical lab test results are incorporated into certified electronic health record technology (CEHRT) 

• Patient lists of patients with a specific condition (e.g., MRSA) 

• Immunization registries data submission 

• Electronic submission of lab results to public health agencies (note: public health agencies often lag 
behind with technology that can accept results) 

• Syndromic surveillance data submission to public health agencies (e.g., ED diagnoses to detect 
sudden increased volumes due to a specific clinical syndrome such as diarrhea) 

TRANSFORMING HEALTHCARE 

Meaningful use presents healthcare providers with an opportunity to strategically lead, improve, and 
transform the quality of care and healthcare delivery to patients. Research and the advancement of HIT 
outcomes offer the ability to improve access to comprehensive health data. Patient-centered health 
information exchange (HIE) has important implications for the future of infection prevention in terms of 
the ability to spot trends and improve infection surveillance tools. 

Trends in Technology 


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Telehealth is used as a means to reach a wide variety of audiences in various locations. Telehealth is 
the use of telecommunications technologies to deliver health-related services and information that 
support patient care, administrative activities, and health education.isThe convenience of telehealth 

supports improved access to care and reduction of related expenses. 

Mobile technology continues to provide rapid and portable access to resources with the introduction of 
new devices designed for easy retrieval of information. Smart phones are used commonly to access the 
Internet and transmit information using a 4G or fourth-generation network. Mobile technology can be 
recognized in several different ways. Knowledge-based systems are defined by the use of mobile 
computing devices to access drug information databases, medical reference manuals, and other 
educational materials. Legacy systems are characterized by point solutions that solve a specific business 
problem or conduct a specific process and are tightly integrated with back-office clinical systems. These 
systems include patient management, tracking, laboratory entry, and viewing. Enterprise systems 
encompass a step forward, incorporating mobile devices into new applications including electronic 
medical records, CPOE, and clinical decision support. 

Most mobility tools used in healthcare are supported by wireless networks, mainly wireless local area 
networks (WLANs). Most organizations that use notebooks and laptops as their primary network access 
platform do so with WLAN. Wireless technology can benefit patient care in several ways. The two-way 
transfer of data process allows for the creation, updating, and deletion of patient records from off-site 
locations. Mobile devices improve the speed of transmission, security, and dependability. Mobile devices 
are very convenient, affording users complete access to most desktop applications literally in the palms 
of their hands. 

The information from most handheld devices can be sent or transferred to desktop or network 
computers through cable or wireless connections. Synchronization also transfers information and 
updates from the larger system to the handheld version. Infrared capabilities allow some handheld 
devices to "beam" or exchange information with other similar devices as long as the devices are in 
close proximity. Beaming also facilitates the transfer of information from appropriately equipped 
handhelds to local or network printers. The addition of digital photography capabilities to handheld 
devices has transformed many handheld devices into diagnostic tools. Other handhelds also incorporate 
cellular telephones, global positioning system (GPS) devices, voice recorders, MP3 players, and wireless 
Internet access. 

Additional trends include interconnected patient monitoring systems that facilitate accurate and timely 
data transfer from devices (like vital signs monitors) directly into the EHR and personal computer tablets 
in place of fixed workstations. 

Intranet Facilitates Networking and Communication 

Organizations continue to make progress in technology in that an increasing amount of information is 
computerized, including paystubs, benefit statements, and newsletters. Intranets, or internal Internet 
systems, are widely used and have increased in popularity; they typically serve as a portal for resources 
and tools. Policies and procedures as well as success stories and data outcomes are posted for ease of 
accessibility and retrieval. A blog, or Web log, is a Web page that serves as a publicly accessible 
personal journal for individuals or, in infection prevention, professionals to dialogue. Blog sites serve as 
a means for dissemination of information on a more personal note. Blogs and shared workspaces on 
intranets provide communication spaces to meet the demand of the population that requires infection 
prevention data. This also facilitates a "green initiative" in that paper documents are minimized. 


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Healthcare Informatics and Information Technology for the Prevention of Infection 

Informatics is the application of computer science and information science to the management and 
processing of data, information, and knowledge. Informatics has become an area of specialization and is 
integrated into many different healthcare realms. 

The application of IT and informatics in preventing infections is evidenced by the use in surveillance for 
HAIs. Interface engines are designed to retrieve pertinent clinical data from the laboratory information 
systems (LISs), enabling the IP to obtain real-time information necessary for intervention. Computerized 
ordering systems help standardize order sets and improve patient safety by building in error-checking 
mechanisms. Decision support tools, artificial intelligence, and evidence-based practices facilitate the 
automation of bundled protocols, such as the ventilator-associated pneumonia bundle. In this example, 
when a patient is ventilated an order is generated to implement the bundle, complete with compliance 
monitoring. The clinical information system (CIS) can be used as an education tool for the IP to 
communicate pertinent information to clinical personnel during patient care documentation activities by 
using pop-up boxes, thereby improving the dissemination of infection prevention knowledge.i9Blogs, as 

mentioned earlier, have found their way into the IP's toolbox, providing an informal messaging system. 
Sophisticated surveillance systems act as liaisons between various information systems pulling data from 
pharmacy, laboratory, and admission/transfer/discharge records and applying algorithms to identify 
potential infections and alerting the IP, as illustrated by Figure 6-3. Computer algorithms have been 
used to identify blood culture results that could be excluded as sources of a CLABSI, effectively offering 
an automated surveillance method for CLABSIs. 2 olnformatics has been used to track employee influenza 

vaccination rates via a network intranet system as part of an effort to effectively capture immunization 
data .21 

Healthcare informatics has been broadened to include the cognitive, information processing, and 
communication tasks involved in medical practice, education, and research. Clinical specialists with 
training in informatics are now being called on to design and develop systems for use in acute and 
long-term healthcare settings. 



Figure 6-3. 

Linking information to the infecti ... „ .—, 

View Image M 

ELECTRONIC VENDOR SOFTWARE 
SOLUTIONS 

The work of the IP includes those activities 
necessary to prevent and control HAIs. This 
includes surveillance, which is key to identifying 
increases in infection rates, recognizing adverse 
trends, and assessing performance 
improvement initiatives. These activities require 
an increasing amount of clerical tasks, including 
manual review of microbiology reports, which 
divert IPs from clinical, education, and 
consultative tasks. Manual surveillance has 
been estimated to consume up to 45 percent of 
an IP's time .22 


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With continued advancement in information technology and electronic medical records, new tools are 
available for the automation of data collection and surveillance.23While these new systems have the 

potential to reduce the clerical time required for surveillance activities,24they must be carefully selected 

to ensure compatibility with existing electronic health record systems in place at a facility, provide the 
necessary features to meet the internal goals of the organization, and be effectively incorporated into 
the IP workflow to optimize infection prevention resources. 2 sThese systems can be complex, drawing 

from various databases and systems, and require a minimum of a semistructured EHR to allow the 
system to reliably capture the necessary data for infection prevention surveillance. The IP workflow 
should be supported and easily merged with the system to ease IP adoption of the system and enhance 
the clinical and administrative duties of IPs in order to maximize their potential to facilitate data review, 
promote rapid detection of outbreaks, and improve infection prevention processes .26 


The Business Case and Vendor Selection Processes 

A structured EHR system and standardized documentation streamline the integration and mapping of 
source data into the vendor system. Available IP software systems should be evaluated for the ability to 
present clinical information, by patient, from a single or multiple healthcare record platforms, including 
EHR nursing and physician documentation, laboratory and microbiology results, radiology reports, 
admit/discharge/transfer status, surgical procedures, device information, and pharmacy or surgical 
medication administration. It is equally important to understand how this electronic clinical information is 
stored in the healthcare system's existing EHR. 

Basic steps for selecting an electronic vendor solution include: 

1. Create business case and obtain approval 

2. Make a formal request for proposal 

3. Schedule vendor product demonstrations 

4. Identify healthcare system subject matter experts in clinical and integration, architecture, and 
security (IT&S) 

5. Make sample electronic data available on DVD beforehand to use during demos 

6. Create a scoring template for functionality and weighting (e.g., clinical 60 percent, and technical 
40 percent) 

7. Obtain consensus and ranking of vendors 

8. Update business case and obtain funding 

9. Finalize vendor of choice with contract 

10. Initiate implementation planning 

a. Configuration of alerts, reports, notifiable diseases 

b. IT&S server, programming, certification 

c. Test environment data feed; validation and testing 

d. Production programming 

e. Go live 

DESIGN AND IMPLEMENTATION FOR WORKFLOW AND EFFICACY 

Organizations may want to invest time and resources into planning and designing the implementation of 
IP software prior to deploying. A well-planned deployment can avoid unexpected problems and lay a 
sound foundation for leveraging the technology to address the challenges facing IPs and aligning and 
standardizing the IP workflow with the system to promote efficiency and continuity. The hypothesis is 
that a planned implementation will increase the likelihood that infection prevention software would help 


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optimize IP resources, shift IP tasks from clerical to clinical, and streamline submissions for public 
reporting. Table 6-1 displays the shift in IP tasks from one experience with a planned implementation 
based on time studies before and after the implementation. 


Table 6-1 Shifts in IP Workflow from Clerical to Clinical with Planned Implementation of Electronic 
Surveillance* 


IP Workflow Categories 

Percent of 

Work Time 

Difference 



Pre¬ 

implementation 

Post¬ 

implementation 


Surveillance 

21% 

26% 

+5 

Public Reporting 

7% 

5% 

-2 

Clinical: Education/preventative interventions 

13% 

23% 

+10 

ClericahReport preparation 

18% 

11% 

-7 

Rounding:Device reports; isolation rounds; hand hygiene 

13% 

13% 

0 

Consulting:Employee/patient exposures; patient isolation status/cohorting (bed 
board); outbreak investigations; reconciliation of isolation status 

10% 

7% 

-3 

Other:Alerts, daily reports 

18% 

16% 

-2 


*Bienvenu SB, Moody J, Hickok J, et al. Optimizing infection prevention resources through 
standardization of workflow integrated with infection prevention software. Am J Infect Control 2013;41 (6, 
Supplement):S21-S22. 

Once the software selection is made, it can be leveraged as a framework for the standardization of the 
IP workflow. The design of the workflow should target the major activities of the IP work day as defined 
by Grota et al., including (1) managing surveillance through the collection and creation of reports, case 
review and analysis, and interpretation of data; (2) public reporting to both national and state agencies; 
(3) daily isolation issues; (4) consultation and teaching; and (5) other activities including policy 
development, product evaluation, and emergency preparedness.27The workflow design should integrate 

with the software to standardize IP work processes, document cases, and report outputs. The workflow 
and the software should work in concert to follow a logical workflow progression to maximize continuity 
in surveillance, reporting, and analysis. 

System templates can be designed to support the IP workflow and ensure that the IP reliably accesses 
the same work datasets defined for each of the major work activities—for example, current alerts for 
notifiable diseases, flags for isolation precautions, positive microbiology or other laboratory findings for 
surveillance, and infection classification. Templates can increase consistency and decrease the potential 
for user errors, thus improving the quality and ease of surveillance. In addition, templates should 
address all work datasets necessary for national and state reporting, including urgent notifiable 
communicable diseases and early identification of HAIs and multidrug-resistant organisms. 

System-specific inputs for documentation of NHSN-defined infection classifications, including CLABSI, 
CAUTI, and SSI, should be predefined to facilitate the consistent selection of required documentation 
elements that are needed to produce the intended infection report outputs. Understanding the selected 
software's design and report output drivers is essential to defining the needed documentation elements 


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to consistently capture each infection type. This approach is recommended in addition to the use of the 
system data scrubbing technology that runs infection classifications through algorithms to determine if all 
criteria are met for NHSN reporting. Consideration may also be given to leveraging the system to 
document nonqualifying NHSN reportable cases (such as community-associated infections and 
secondary infections) to facilitate more robust report outputs and audit trail documentation that can be 
used for validation of case classification, especially in light of CMS HAI validation. 

The organization's surveillance strategies should be reevaluated during the preimplementation period. 
Consideration should be given to leveraging the efficiencies of an electronic surveillance methodology to 
expand surveillance beyond targeted areas identified in the annual risk assessment. Areas of expanded 
surveillance may include whole house surveillance (all patient units), defining alerts for organisms of 
interest based on local epidemiology, syndromic surveillance (such as sepsis), and utilization of system 
functionality to support infection prevention rounding. Identified surveillance strategies should be 
incorporated into the custom standardized workflow, system design, and training. 

System outputs should be predefined to facilitate on-demand infection reports and dashboards to meet 
the organization's needs. Optimally, system reports and dashboards will be developed to replace current 
reporting methods that are often manual or require assimilation of data from various sources. Careful 
planning and collaboration with key stakeholders is needed to transition to system reports by identifying 
needed reports, developing an interim process to report legacy data while new data is accumulating 
within the system, and considering new report opportunities afforded by the system, such as "Days 
Since Last Infection" reports. 

System training should be developed to reinforce the workflow design conceptualized by the 
organization. This can be accomplished by introducing software modules in concert with daily IP 
workflow to ease the transition from manual to electronic processes. The training should include the 
basics of the software as well as the organization's customization of the software and system templates 
to ensure accuracy and consistency for reporting and surveillance. Optimally, training will be conducted 
with a small student to teacher ratio, such as 10:2, and presented in person by the vendor trainer and a 
trainer from the organization that is familiar with the customization of the workflow and the system 
usage. Training will typically be conducted in the facility's live infection prevention surveillance system 
environment and include classroom work as well as applied learning sessions via coaching calls or 
WebEx sessions to support the end user during the first 2 to 3 months. This approach will assist the 
student end user in gaining confidence in their abilities and reinforce appropriate utilization of the 
system and customized workflow. In addition to vendor system training guides, the development of an 
organizational customization guide is recommended to ensure continuity of practice and system 
utilization. 

By anticipating the essentials of implementation, an organization can develop and design customized 
standards that will set the stage for successful deployment and adoption of an electronic infection 
prevention surveillance system. This, in turn, will provide opportunity to optimize IP resources, improve 
data integrity for surveillance and reporting, and lay a foundation to improve patient outcomes and 
reductions in HAIs. 

Conclusions 

Healthcare IT supports improvements in the efficacy of care delivery and patient safety as well as the 
expansion of surveillance and epidemiologic population studies. 


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The trend in healthcare IT is for devices to get smaller and for their capabilities and capacity to 
increase. New devices offer faster and more integrated features related to functionality, security, and 
privacy. Wireless technology continues to grow and expand, allowing continual and uninterrupted access 
to online data, tools, and resources. Data and applications interconnect across multiple software 
platforms. Patient care devices log and track increasing amounts of data. 

For the IP, these trends mean broader and more readily available access to information, analysis, and 
communication. Information technology is a powerful component of a comprehensive infection prevention 
program. The benefits of healthcare IT include optimizing evidence-based care practices, identifying 
patients at highest risk of infection in order to implement strategic interventions, and improving 
regulatory reporting. IPs should embrace and adopt IT in order to enhance the effectiveness and 
efficiency of infection prevention and control programs and to reallocate infection prevention resources 
from clerical duties to clinical leadership activities. 

Future Trends 

Healthcare informatics and the field of infection prevention will continue to be positively impacted 
through development of technology advances. The portability, interconnectivity, availability, and breadth 
of information will guide decision making in patient care, patient safety, research, and infection 
prevention strategies. 

International Perspective 

Healthcare and surveillance IT has effectively removed barriers between countries around the globe. 

The effective use of shared data was demonstrated during the 2002 to 2003 SARS epidemic and 
continues with the dissemination of data about novel strains of avian and swine influenza viruses. The 
World Health Organization (WHO) provides current data via the use of their website and reaches a 
broad international audience that supports dissemination of critical epidemiological data trends. 

WHONET software is an example of an internationally based program. This Windows-based database 
software was developed for the management of microbiology laboratory data and the analysis of 
antimicrobial susceptibility test results. WHONET can be obtained via the WHO website .28 

The global expansion of mobile devices, software applications, and Web-based technology tools promote 
the ability to perform surveillance activities in resource limited settings. 

Supplemental Resources 

Evans RS, Larsen RA, Burke RM, et al. Computer surveillance of hospital-acquired infections and 
antibiotic use. JAM/42008; 15:506-512. 

Gundlapalli AV, Olson J, Smith SP, et al. Hospital electronic medical record-based public health 
surveillance deployed during the 2002 Winter Olympic Games. Am J Infect Confro/2007;35:163-171. 

Murphy DM. From expert data collectors to interventionists: changing the focus for infection control 
professionals. Am J Infect Confro/2002;30:120-132. 

Organization Websites 


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Agency for Healthcare Research and Quality. Available at: http://www.ahra.aov.com . 

American Medical Informatics Association. Available at: http://www.amia.org . 

American Nursing Informatics Association. Available at: http://www.ania.org . 

Certification Commission for Healthcare Information Technology. Available at: http://www.cchit.org 
Healthcare Information and Management Systems Society. Available at: http://www.himss.org . 
Information Technology Association of Canada. Available at: http://www.itac.ca . 

International Medical Informatics Association. Available at: http://www.imia.org 

Appendix A 

Basic Principles 

What is information technology? Information is defined as the communication or reception of knowledge 
or intelligence. Technologyls defined as the practical application of knowledge. Information technologyls 
how the data we gather is handled, with data being the factual information. It is the use of modern 
technology to create, store, exchange, and manipulate information and use it as a basis for reasoning, 
discussion, or calculation. Information technology is defined as "the study, design, development, 
implementation, support or management of computer-based information systems, particularly software 
applications and computer hardware."llnformation technology deals with the use of electronic computers 

and computer software to convert, store, protect, process, transmit, and securely retrieve information. 

Changes or "upgrades" in information technology occur on an almost daily basis. Information technology 
continues to progress at a rapid pace. Data punch cards of the 1960s and 1970s have been replaced 
by microprocessors, tablet computers, personal digital assistants, wireless networks, and streamlined 
Internet. Keeping up with such changes requires us to continually learn new ways to speak, work, and 
interact. Following are terms that may be encountered in practice: 

• American Standards Institute (ANSI): The standard-setting body that approves the character sets and 
processing protocols used in computing. 

• American Standard Code for Information Interchange (ASCII): The code set that is the basic 
foundation of technology. 

• Cookie: A packet of data passed from one computer application to another and stored to be retrieved 
later. 

• Electronic health record (EHR): A longitudinal electronic record of patient health information generated 
by one or more encounters in any care delivery setting. 

• Electronic medical record (EMR): The legal record created in hospitals and ambulatory environments 
that is the source of data for the EHR. 

• Relational database management system (RDBMS): This is a database management system in which 
data are stored in the form of tables and the relationship among the data is also stored in the form 
of tables. 

• File transfer protocol (FTP): This is the simplest and most secure way to exchange files over the 
Internet. When downloadinga file from the Internet you're actually transferringthe file to your computer 


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from another computer over the Internet, representing the "T" (transfer) in FTP. 

• Hypertext markup language (HTML): The language recognized for Web page development. 

• Extensible markup language (XML): The language currently in the forefront of Web development. 

• Health level seven (HL7): Used to define messages for laboratory and other clinical results and an 
ANSI-approved clinical message standard used in the United States and internationally. 

• Logical Observations Identifiers Names and Codes (LOINC): A standard that identifies clinical 
questions, variables, and reports. 

• Systematized Nomenclature of Medicine (SNOMED): Identifies procedures and possible answers to 
questions regarding test results. 

• Wireless fidelity (WiFi): A radiofrequency standard used to connect devices, such as computers, using 
a wireless connection, replacing cables in the connection process. 

IPs collect and manage large amounts of data. Effective use of the data is the fundamental element of 
a successful program. Information technology is used extensively in the day-to-day activities of the IP as 
the demand for more data continues to increase. Information technology comes in many forms; 
therefore, it is helpful for the IP to be familiar with some of the basic terms and concepts. These include 
the following: 

• Hardware: The differences among a mainframe computer, network computer, personal computer, 
laptop, and handheld device primarily relate to their storage capacity, speed, cost, connectivity, typical 
users, and typical uses. Most computers include a central processing unit (CPU), memory (random- 
access memory [RAM], and read-only memory [ROM]), hard drive, one or more removable storage 
device (i.e., disk, CD or DVD drive, memory card, flash or jump drive), and networking or 
communications devices (network card, modem, etc.). Newer devices can operate using flash memory 
and contain very little internal memory capability. Most laptops use built-in wireless functions, thereby 
eliminating the need for external wireless cards. The typical computer also includes such input 
devices as a mouse, keyboard, scanner, touchpad, or stylus, and such output devices as a visual 
display unit, monitor, audio speakers, and printer. 

• Interface: Communication with two independent systems requires an interface. An interface can be 
hardware, software, or user interfaces. 

• Software: Software typically includes the operating system, networking software, and application 
software such as word processors, spreadsheets, databases, presentation tools, email processors, 
Web browsers, desktop publishing programs, and multimedia applications. 

• Networking: Local area networks (LANs) connect computers within a single site, and wide area 
networks (WANs) link computers in multiple sites. Intranets are contained as internal networks for 
storing and sharing data. Many intranets use structured query language (SQL) platforms. Networking 
is also fostered by integrated service digital network (ISDN) connections, satellite communications, 
public switched data network (PDSN) systems, modems, digital connections, and wireless devices. 

• The Internet: The World Wide Web, email, and search engines facilitate the transfer of data among 
computers and users. 

• Security, privacy, and copyright: Rapid advances in our ability to share data continue to test data 
security measures. Securing individual and corporate data stored on personal and network computers 
challenges current infrastructures and requires continuous monitoring. The ability to readily retrieve 
information from the Internet also raises concern over copyright infringement and potential 
manipulation of a software product for personal use. Most healthcare facilities employ a security 
officer in their information technology department whose primary focus is data security. 


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INFORMATION TECHNOLOGY 

How Computers Work 
Hardware 

Hardware in computer terms refers to a mainframe or central computer that acts as the primary device 
for management of multiple individual users. A server is a computer or device specifically designed for a 
certain task.29An example of a server is a file server dedicated to the storage of files. This type of 

server can be accessed by individuals wanting to store information in a secure place, typically on a 
LAN. Servers are designed to perform only certain tasks; however, their capabilities are expanded when 
used in a multioperating system. Multioperating systems are capable of supporting hundreds of users, 
and the mainframe or server may support a range of devices, including personal computers, laptops, 
workstations, wireless and handheld devices, and telecommunications and telephony systems. 

Regardless of size or speed, all computers rely on a central processing unit (CPU) to control all 
functions, basic and advanced. The CPU is the "brain" of the computer and is responsible for managing 
the transfer of data from one part of the computer to another and performs multiple functions, such as 
process control, arithmetic and logic, memory access, decoding, buffering, and storage. CPUs are 
known more commonly as processors or microprocessors and are the most important component of a 
computer. 

The computer relies on two types of internal memory. ROM is built-in memory that contains data and 
programming that are required to make the computer operate ("booted" on startup or refreshed on 
login). ROM can be read but not written by the computer. RAM is available to the computer for various 
processing and storage functions. Memory is measured by the amount of data processed in a given 
time period in bits, bytes, kilobytes (KB), megabytes (MB), gigabytes (GB), terabytes (TB), and more. 

The CPU speed, amount of RAM, and processing (hard drive) speed and capacity affect the computer's 
overall performance. 

Software 

Software is a computer program that provides the instructions that enable the hardware to work. 
Operating software or system software is the platform or framework that drives the computer. The 
operating system (OS) controls the underlying function of a computer, including the interplay of the 
various hardware and software components. A common operating system for personal computers and 
business networks is Windows, developed by Microsoft. Computers and other devices made by Apple 
Computer rely on the Mac OS. Certain handheld devices utilize the Palm OS or Windows Mobile. Newer 
generations of consumer electronics and appliances are also incorporating one or more operating 
systems to make them compatible with other networked devices. 

Some operating systems include basic applications such as text writing and editing, installation of 
hardware and peripherals, networking, a calculator, and basic audio and video functions. Most users, 
however, rely on other software applications such as word processors, spreadsheets, databases, 
presentation tools, email processors, Internet browsers, and multimedia programs. 

Data Collection, Management, and Reporting 

Infection prevention relies on data to drive improvement efforts. Data are elements of a total entity, and 
each piece of data can affect an outcome on a variety of levels. For example, collection of raw data 


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such as a line listing of patients with multidrug-resistant organisms can provide essential information for 
investigation of a suspected outbreak. From the line listing, more detailed analysis can then be 
performed such as calculation of monthly incidence (e.g., frequency per 1,000 patient days) of select 
microorganisms of epidemiological importance in the facility sorted by patient unit. 

Once collected, data must be put in an accessible and stable database to be useful. An IP typically uses 
the same data for multiple reports and purposes, such as surveillance, managing infections, patient 
safety, and sentinel event reporting. A well-organized database is tremendously powerful and can 
provide the information needed to monitor and perhaps curtail the spread of infection. 

Data Collection 

Daily surveillance requires the collection, review, analysis, and storage of data. Any data collection form 
should be standardized to eliminate duplicate efforts and prevent misinterpretation by the data 
collector(s). Formatting for ease of use facilitates correct data collection and eliminates missing data. 

Scanned forms are fairly easy to develop using specialized software programs, but they may be difficult 
to use and to modify, and only provide users with a static copy of the information. Printed laboratory 
reports are of limited use because the data must be extracted and stored elsewhere. Retrieval of data 
can now occur with the use of the EHR. Healthcare facilities are moving away from the paper patient 
medical record and more toward the electronic record. The medical informatics professionals realized 
the need for interoperability of EHRs and created standards for data coding and communication. 30 The 

Office of the National Coordinator for Health IT (ONC) authorized certification bodies that provide a 
certification process for EHRs so that interoperability is improved and allow decision-makers the ability to 
adopt EHRs more easily. Information regarding these certification processes can be found at the 
Certification Commission for Healthcare Information Technology website.3iPotential utilization of the EHR 

for surveillance of HAIs has recently been reviewed .25 

The optimal collection method would be seamless and transparent to the user—one that enables the 
laboratory systems to "talk" or interface with other computer systems—but such systems are impractical 
for most IPs because of the need for advanced computer skills, the high costs of programming, and the 
amount of equipment required. The need to retrieve and access large amounts of data specific to a 
particular patient population has prompted organizational leaders to review surveillance systems. The IP 
is poised to take the lead on reviewing the proposed systems and offering recommendations to the 
capital committees and executives. The IP should be familiar with the terms necessary to converse with 
the IT department and serve as the liaison between them and the vendor offering the system. Infection 
preventionists should be part of the implementation team to ensure the needs of the department are 
met during the system initialization. Changes made after implementation are more difficult, and 
organizations can incur additional expenses. 

For institutions that are not ready or unable to purchase a system, there are relatively inexpensive and 
easy-to-use data collection and management tools available. The CDC offers data storage, retrieval, and 
analysis through NHSN. NHSN replaced the National Nosocomial Infection Surveillance System (NNIS) 
and offers Web-based interoperability. NHSN, as a reporting tool, also provides a means by which the IP 
can use datasets of entered data and customize data analysis and reports. The options in NHSN include 
line listings, control charts with aggregated data averages, and optional in-depth analysis using 
embedded SAS analytics. The capabilities of NHSN are increasing as more states and CMS legislative 
mandates are requiring public reporting using NHSN. Growing from an initial base of 300 hospitals in 
2005 to over 2,000 by November 2008, there were 4,444 enrolled healthcare facilities reporting at least 


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1 month of denominator data into NHSN in 2012.32Some of this is attributable to legislative mandates 

for public reporting of HAI data; however, a substantial portion is unrelated to these requirements. This 
growth in NHSN enrollees also is occurring in smaller hospitals, resulting in a more diverse and accurate 
picture of the epidemiology of HAIs in all acute care settings. 

Data Management 

Most database management systems allow users to enter, edit, view, and print data from one or more 
tables. This may make the database appear similar to a spreadsheet application, but there are three 
distinct differences between a relational database management system (RDBMS) and a spreadsheet 
application. First, a relational database is designed to handle large amounts of data efficiently. Second, 
in a relational database, two or more tables can be easily linked and can be viewed as one, as 
illustrated in Figure 6-1. Finally, a relational database repeats only data that link other components, 
thereby minimizing the duplication of information. 

When developing a database, clinical and information systems personnel must consider the following 
elements: 

• Selection of a primary key or identifier (e.g., patient medical record or billing number): The unique 
identifier enables records to be sorted and linked. Many database applications automatically assign a 
unique number to each record as it is created. 

• Categorization of the information: Label data appropriately to foster rapid searching. 

• Providing ready access to the data, but protecting its security: If a number of individuals need access 
to the database, its location becomes a strategic decision. For example, a database that must be 
shared by multiple users may be stored on a network server rather than on a local hard drive. 
However, it may be necessary or prudent to limit access to the database by using passwords in order 
to control and preserve the integrity of the data. 

• Retrieval of the data: Create filters to isolate records that match a defined set of criteria, and use 
sorting to organize the records in a specific order based on the contents of one or more fields. 

Sorting can be done alphabetically, numerically, or by specified characteristics (i.e., male or female). It 
is advantageous to use these simple functions whenever possible to provide a standardized format for 
viewing. Sorting and filtering can be used to provide a standard format for viewing the data. Most 
database applications include these functions on the toolbar. 

• Queries to link data elements: Create several tables related to the original records to enable more 
efficient and productive use of the data for case investigation and epidemiological research. Tables 
may be based on a "one-to-one" or a "one-to-many" relationship. One-to-many relationships are 
inherently more powerful. For instance, there may be a link between a line listing of patients with 
multidrug-resistant organisms and a table with reportable disease findings or bloodstream infections. 

• Back up of data: The database should be regularly copied or backed up. Frontend storage refers to 
the process of backing up the data locally, for example, using a hard drive, CD, or a DVD or external 
backup device. Backend storage refers to larger systems used to back up data from multiple 
computers or entire networks. Backing up data is crucial and should be the first consideration when 
developing a database. Lost data are difficult and expensive to retrieve if that option is even 
available. 

• Export and import of data as appropriate: Data may need to be shared internally and externally in a 
format that can be used by other software applications. Most often, this requires converting the data 
from a database format into another format such as a text file, spreadsheet, or table. 


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• Analysis of the data 

• Reporting of the data 

• Integration of a macro-enabled system for checking errors: Macros are used to define a sequence of 
actions that automate repetitive database functions, including opening, printing, and closing certain 
reports each time a command is executed. Most database applications include some reporting 
macros. Others can be written or purchased. 

Data Analysis 

Analyzing data can be cumbersome, labor intensive, and sometimes frustrating. Most analysis is 
conducted using queries, which are questions asked of the data. There are several types of queries, as 
follows: 

• "Select" queries extract data from one or more tables and display them in a tabular form. 

• "Crosstab" queries summarize data from one or more tables in the form of a spreadsheet. 

• "Action" queries create new tables from query tables or make major changes to already-defined 
tables. 

• "Parameter" queries use a single query over and over and only make simple changes to the original 
table. 

It is extremely important that any analysis be validated to ensure the integrity and quality of the data. 
Using the right software also maximizes the usefulness of the data. Infection prevention departments 
should focus on moving from a data-rich, information-poor (DRIP) environment to a recognized resource 
for accurate and timely data. This includes choosing software that matches the needs and comfort level 
with technology of the end users. The following are three of the most widely used statistical analysis 
software applications: 

• S-Plus: A software package designed for exploratory data analysis and statistical mining; a flexible 
program capable of high-powered data analysis. 

• SAS: A suite of software for information delivery that is built around four common tasks (data access, 
management, analysis, and presentation); additional components can be added later. 

• SPSS: Software designed for data access, data preparation, analytical reporting, statistics, and 
predictive modeling. 

Although these programs are used for data analysis, they may require more specialized training; 
therefore, the IP should use software that is familiar yet powerful, such as spreadsheet or relational 
database software. 

Data Reporting 

Reporting is usually the final step in most database applications. How data are reported can affect their 
impact. Good reports make key information and conclusions readily identifiable to the intended 
audience. A data report typically contains (1) the topic (what the report is about); (2) a one-sentence 
summary of the data; (3) the date of the report, to coincide with the date the final data were gathered; 
(4) the report period (start date to end date); (5) titles of rows or categories (types of data and relation 
to other data); and (6) page numbers and other reference points. 

Graphs can provide a sequential method for displaying data and can facilitate the tracking of trends. 
There are several types of graphs and charts, including line charts, pie charts, bar graphs, control 


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charts, line graphs, run charts, stacked area charts, stacked column charts, and histograms. 

References 

[1] Joos IM, Nelson R, Smith M. Introduction to computers for healthcare professionals, 6th ed. Burlington, MA: Jones & 
Bartlett Learning, 2014. 

[2] Saba V, McCormick K. Essentials of Nursing Informatics, 5th ed. New York: McGraw-Hill Companies, 2011. 

[3] Committee to Reduce Infection Deaths (RID). State Legislation and Initiatives on Healthcare-Associated Infections. 

RID website. 2011. Available at: http://www.hospitalinfection.org/leqislation.shtml . 

[4] U.S. Department of Health & Human Services (HHS). National Action Plan to Prevent Health Care-Associated 
Infections: Road Map to Elimination. HHS website. 2013. Available at: 

http://www.hhs.aov/ash/initiatives/hai/actionplan/ . 

[5] QualityNet. Hospital Inpatient Quality Reporting (IQR) Program Overview. QualityNet website. 2013. Available at: 

https://www.qualitvnet.org/dcs/ContentServer? 

c=Paqe&paqename=QnetPublic%2FPaqe%2FQnetTier2&cid= 1138115987129. 

[6] The Direct Project. Direct Abstract Model Version 2.2. The Direct Project website. 2010. Available at: 

httpU/wiki.directproiect.orq/Direct+Abstract+Model . 

[7] Kristianson KJ, Ljunggren H, Gustafsson LL. Data extraction from a semi-structured electronic medical record 
system for outpatients: a model to facilitate the access and use of data for quality control and research .Health 
Informatics U2009; 15(4):305-319. 

[8] National Center for Emerging and Zoonotic Infectious Diseases. Importing Patient Safety Procedure Data. 2014 [cited 
2013 December 18]; Available at: http://www.cdc.qov/nhsn/PDFs/lmportinqProcedureData 2014v.8.1.pdf . 

[9] National Health Safety Network. How to Import Patient Safety Procedure Data. Centers for Disease Control and 
Prevention website. 2013. Available at: http://www.cdc.gov/nhsn/PDFs/slides/lmportProcedureData.pdf . 

[10] Health Level Seven International (HL7). HL7 Standards named in the HHS Final Rule for Meaningful Use Legislation. 
HL7 website. 2013. Available at: http:/www.hl7.orq/implement/standards/hhsifr.cfm?ref=announce . 

[11] Centers for Disease Control and Prevention (CDC). About Electronic Reporting to NHSN (CDA). CDC website. 2013. 
Available at: http://www.cdc.qov/nhsn/faqs/FAQ-electronic-reportinq-cda.html#qen3 . 

[12] QualityNet. Transcript-Validation Blood and Validation Urine Culture Templates. QualityNet website. 2013. Available 

at: http://www.qualitvnet.org/dcs/ContentServer? 

c=Paqe&paqename=QnetPublic%2FPaqe%2FQnetTier2&cid=1228760487021 . 

[13] Centers for Disease Control and Prevention (CDC). PHIN Messaging Guide for Syndromic Surveillance. CDC 
website. 2011. Available at: 

http://www.cdc.qov/phin/librarv/quides/PHIN MSG Guide for SS ED and UC Data vl O.pdf . 

[14] Florida Department of Health. Surveillance Systems. Florida Department of Health website. 2013. Available at: 

http://www.floridahealth.qov/diseases-and-conditions/disease-reportinq-and-manaqement/disease-reportinq-and- 

surveillance/surveillance-svstems.html . 

[15] Ortiz E, Clancy CM, AHRQ. Use of information technology to improve the quality of health care in the United States. 
Health Serv Res 2003;38(2):xi-xxii. 

[16] Centers for Medicare & Medicaid Services (CMS). EHR Incentive PRogram. CMS website. 2013. Available at: 

http://www.cms.qov/Requlations-and-Guidance/Leqislation/EHRIncentiveProqrams/index.html? 


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redirect=/ehrincentiveproqrams/ . 

[17] Centers for Medicare & Medicaid Services (CMS). The Medicare and Medicaid Electronic Health Record (EHR) 
Incentive Programs: Stage 2 Toolkit. CMS website. 2013. Available at: http://www.cms.aov/Reaulations-and- 
Guidance/Leqislation/EHRIncentiveProqrams/Downloads/Staae2 Toolkit EHR 0313.pdf . 

[18] Dixon BE, Hook JM, McGowan JJ. Using Telehealth to Improve Quality and Safety: Findings from the AHRQ Health 
IT Portfolio. Rockville, MD: Agency for Healthcare Research and Quality, 2008. 

[19] McGonigle D, Mastrian K. Nursing Informatics and the Foundation of Knowledge. Sudbury, MA: Jones and Bartlett 
Publishers, 2009. 

[20] Woeltje KF, Butler AM, Goris AJ,et al. Automated surveillance for central line-associated bloodstream infection in 
intensive care units. Infect Control Hosp Ep/cfem/o/2008;29(9):842-846. 

[21] Bertin M, Scarpelli M, Proctor AW,et al. Novel use of the intranet to document health care personnel participation in 
a mandatory influenza vaccination reporting program. Am J Infect Control 2007;35(1):33-37. 

[22] Stone PW, Dick A, Pogorzelska M,et al. Staffing and structure of infection prevention and control programs. Am J 
Infect Control 2009;37(5):351-357. 

[23] Hota B, Jones RC, Schwartz DN. Informatics and infectious diseases: What is the connection and efficacy of 
information technology tools for therapy and health care epidemiology? Am J Infect Confro/2008;36(3):S47-S56. 

[24] Leal J, Laupland KB. Validity of electronic surveillance systems: a systematic review. J Hosp /nfecf2008;69(3):220- 
229. 

[25] Atreja A, Gordon SM, Pollock DA,et al., and the Healthcare Infection Control Practices Advisory Committee. 
Opportunities and challenges in utilizing electronic health records for infection surveillance, prevention, and control. 
Am J Infect Confro/2008;36(3 Suppl):S37-S46. 

[26] Greene LR, Cain TA, Khoury R, et al. APIC Position Paper: The Importance of Surveillance Technologies in the 
Prevention of Healthcare-Associated Infections (HAIs). APIC website. 2009. Available at: 

http://www.apic.org/Resource /TinvMceFileManaqer/Position Statements/Surveillance-Technoloqies-position- 

paper-2009.pdf . 

[27] Grota PG, Stone PW, Jordan S,et al, Electronic surveillance systems in infection prevention: organizational support, 
program characteristics, and user satisfaction. Am J Infect Confro/2010;38(7):509-514. 

[28] World Health Organization (WHO). WHONET Software. WHO website. 2013. Available at: 

http://www.who.int/druqresistance/whonetsoftware/en/index.html . 

[29] Hebda T, Czar P, Mascare C. Handbook of Informatics for Nurses and Health Care Professionals. Upper Saddle 
River, NJ: Pearson Prentice Hall, 2005. 

[30] Agency for Healthcare Research and Quality (AHRQ). Health information technology: best practices transforming 
quality, safety and efficiency. AHRQ website. 2012. Available at: http://healthit.ahra.gov . 

[31] Certification Commission for Healthcare Information Technology (CCHIT). About CCHIT. CCHIT website. 2006. 
Available at: https://www.cchit.org/about . 

[32] Dudeck MA, Weiner LM, Allen-Bridson K, et al. National Healthcare Safety Network (NHSN) report, data summary 
for 2012, Device-associated module. Am J Infect Confro/2013;41(12):1148-1166. 


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Copyright © 2016 by the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) 

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APIC Implementation Guide 


Guide to Infection 
Prevention in Emergency 
Medical Services 


t* RPIC 


About APIC 

APIC’s mission is to create a safer world through prevention of infection. The 
association’s more than 14,000 members direct infection prevention programs 
that save lives and improve the bottom line for hospitals and other healthcare 
facilities. APIC advances its mission through patient safety, implementation 
science, competencies and certification, advocacy, and data standardization. 



About the Implementation Guide series 

APIC Implementation Guides help infection preventionists apply current scientific knowledge and best practices to 
achieve targeted outcomes and enhance patient safety. This series reflects APIC’s commitment to implementation science 
and focus on the utilization of infection prevention research. Topic-specific information is presented in an easy-to- 
understand-and-use format that includes numerous examples and tools. 

Visit www.apic.org/implementationguides to learn more and to access all of the titles in the Implementation Guide 
series. 


Copyright © 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) 

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any 
form or by any means, electronic, mechanical, photocopied, recorded, or otherwise, without prior written permission of 
the publisher. 

Printed in the United States of America 
First edition, January 2013 
ISBN: 1-933013-54-0 

All inquiries about this guide or other APIC products and services may be directed addressed to: 

APIC 

1275 K Street NW, Suite 1000 
Washington, DC 20005 
Phone: 202-789-1890 
Fax: 202-789-1899 
Email: info@apic.org 
Web: www.apic.org 
Email: info@apic.org 
Web: www.apic.org 

Disclaimer 

APIC provides information and services as a benefit to both APIC members and the general public. The material 
presented in this guide has been prepared in accordance with generally recognized infection prevention principles and 
practices and is for general information only. It is not intended to provide, or act as a substitute for, medical advice, 
and the user should consult a health care professional for matters regarding health and/or symptoms that may require 
medical attention. The guide and the information and materials contained therein are provided “AS IS”, and APIC 
makes no representation or warranty of any kind, whether express or implied, including but not limited to, warranties 
of merchantability, noninfringement, or fitness, or concerning the accuracy, completeness, suitability, or utility of any 
information, apparatus, product, or process discussed in this resource, and assumes no liability therefore. 





Guide to Infection Prevention in Emergency Medical Services 


Table of Contents 

Acknowledgments.4 

Declarations of Conflicts of Interest and Disclaimer.6 

Introduction.8 

Section 1: Guide Overview.9 

Section 2: Epidemiology and Pathogenesis: Infectious Diseases in EMS.12 

Section 3: Risk Factors/Risk Assessment in EMS.23 

Section 4: Surveillance.28 

Section 5: Engineering and Work Practice Controls and Personal Protective Equipment.32 

Section 6: Occupational Exposure Health Issues.43 

Section 7: Bioterrorism and Infectious Disease Emergency Preparedness.65 

Section 8: Education, Training, Compliance Monitoring, and Summary.71 

Appendix A: Sample Ambulance Cleaning Procedures.78 

Appendix B: Sample Exposure Control Plan.80 

Appendix C: Definition of Terms.83 

Appendix D: Acronyms and Abbreviations.86 


Association for Professionals in Infection Control and Epidemiology 3 


















Guide to Infection Prevention in Emergency Medical Services 


Acknowledgments 


Lead Author 

Janet Woodside, RN, MSN, COHN-S 

EMS Program Manager, Portland Fire and Rescue, Portland, OR 
Authors 

Terri Rebmann, PhD, RN, CIC 

Associate Professor, Institute for Biosecurity, Saint Louis University, School of Public Health, 

Saint Louis, MO 

Carolyn Williams, RN, BSN 

Occupational Health/Infectious Disease Program Manager, City of Portland, Portland, OR 

Jeff Woodin, NREMT-P, FAHA 
Tualatin Valley Fire and Rescue, Tigard, OR 

Research Assistant 

Martin B. Schopp 

EMS Intern, Portland Fire and Rescue, Student Nurse, Concordia University, Portland, OR 
Reviewers 

Linda Bell, MSN, ARNP, EMT-P 

Programs Coordinator, Consultant Services, Middleburg, FL 
Greg Bruce A-EMCA 

CHICA-Canada, Platoon Supervisor/Infection Control Officer, County of Simcoe Paramedic Services, 
Ontario, Canada 

William E. Coll, BA, MPUB AFF, LP, REHS 

Clinical Commander/ICO, Austin/Travis County EMS, Austin, TX 

Jeffrey D. Ferguson, MD, FACER MS-HES, NREMT-P 

Assistant Professor of Emergency Medicine, Medical Director, Vidant Medical Transport, Assistant EMS 
Director, Pitt County, NC; Brody School of Medicine, East Carolina University, Greenville, NC 

Louis Gonzales, BS, LP 

System Coordinator - Performance Improvement and Research, Senior Science Editor, American Heart 
Association, Office of the Medical Director, Austin/Travis County EMS system, Austin, TX 


4 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Arthur Mata 

Medical Coordinator, Training Division, City of Flint, Michigan Fire Department (Retired), National 
Fire Academy Instructor - EMS 

Katherine H. West, BSN, MSEd, CIC 

Infection Control/Emerging Concepts, Manassas, VA 

Production Team 

Managing Editor 
Thomas Weaver, DMD 
Director, Professional Practice 

Association for Professionals in Infection Control and Epidemiology, Inc. 

Project Management and Production Oversight 
Anna Conger 

Sr. Manager, Practice Resources 

Association for Professionals in Infection Control and Epidemiology, Inc. 

Layout 

Meredith Bechtle 
Maryland Composition 

Cover Design 
Sarah Vickers 
Art Director 

Association for Professionals in Infection Control and Epidemiology, Inc. 


Association for Professionals in Infection Control and Epidemiology 5 



Guide to Infection Prevention in Emergency Medical Services 


Declarations of Conflicts of Interest 


Linda Bell, MSN, ARNP, EMT-P, serves as national faculty for the American Heart Association (AHA), 
serves on the AHA Task Force #3 Committee, and is owner of Community Training Center through 
AHA. 

Greg Bruce, A-EMCA, has nothing to declare. 

William E. Coll, BA, MPUB AFF, LP, REHS, has nothing to declare. 

Jeffrey D. Ferguson, MD, FACEP, NREMT-P, has nothing to declare. 

Louis Gonzales, BS, LP, has nothing to declare. 

Arthur Mata has nothing to declare. 

Terri Rebmann, PhD, RN, CIC, has nothing to declare. 

Martin Schopp has nothing to declare. 

Carolyn Williams, RN, BSN, has nothing to declare. 

JefFWoodin, NREMT-P, FAHA, has nothing to declare. 

Janet Woodside, RN, MSN, COHN-S, has nothing to declare. 

Katherine H. West, BSN, MSEd, CIC, has nothing to declare. 


6 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Disclaimer 


The Guide to Infection Prevention in Emergency 
Medical Services is advisory and informational 
and is intended to assist and guide EMS agencies, 
including Public Safety and Fire, in providing 
a safe workplace through effective Infection 
Prevention programs adapted to the needs 
of EMS system responders. Although many 
regulations are introduced in this guide, each 
EMS agency should be familiar with, implement, 
and comply with state and federal regulatory 
requirements. 


It is the intent of APIC to enhance access of 
infection prevention information through the 
content, references, and resources contained 
within this guide. Resources are continuously 
being updated, and APIC has made every 
effort to present the most current information, 
including information maintained by other public 
and private organizations. This information is 
useful; however, APIC cannot guarantee the 
accuracy, relevance, timeliness, or completeness of 
information developed from outside sources. 


Association for Professionals in Infection Control and Epidemiology 7 



Guide to Infection Prevention in Emergency Medical Services 


Introduction 


Emergency Medical Services (EMS) system 
responders deliver medical care in many unique 
and oftentimes dangerous environments. They 
render care to increasingly mobile populations 
who potentially have a higher likelihood of having 
an infectious or emerging disease. In addition 
to treating accident victims of every nature 
(vehicular, falls, cuts, burns, and more), they treat 
the homeless, nursing home patients, trauma 
victims, and the critically ill with multiple diseases 
and infections. They have unique concerns 
such as suspect searches, communal living 
arrangements, and the need to clean and disinfect 
their work equipment. Like many other healthcare 
professionals, they face ever-increasing exposures 
to infectious diseases. 

Many of the agencies that employ EMS system 
responders are not hospital-based and therefore 
may not have the same knowledge of the 
importance of infection prevention as healthcare 
facilities. Many EMS agencies lack funding 
and have limited staffing. Infection prevention 
resources exist, but they are not easy to find. 
Resources for EMS system responders, such as 
the United States Fire Administration Guide to 
Managing an Emergency Service Infection Control 
Program (2002) and Infectious Diseases and the 


Fire and Emergency Services (2001), are out of 
date and many changes have taken place since 
they were published. APIC saw a need to develop 
this Infection Prevention Guide because EMS 
agencies, including public safety and fire, needed 
a comprehensive, easy-to-use guide to serve as 
a resource to develop or enhance their current 
knowledge of infection prevention strategies. The 
information contained in this guide is intended as 
a roadmap to develop a comprehensive infection 
prevention program. 

For the purpose of this guide, all EMS personnel 
will be referred to as EMS system responders. 

This group encompasses all paid and volunteer 
paramedics and emergency medical technicians 
(EMTs) on ambulances, first responders, fire 
paramedics and firefighter EMTs, police, and 
public safety officers. Although most EMS issues 
are similar, there are some differences among EMS 
system responders. Every effort has been made to 
address those differences. 

This Guide to Infection Prevention in EMS 
is intended to assist in keeping EMS system 
responders and the patients they care for safe and 
healthy while reducing their exposure risks. 


8 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Section 1: Guide Overview 


Purpose and scope 

The purpose of this guide is to provide Emergency 
Medical Services (EMS) system responders and 
their organizations with a practical resource 
to infection recognition and prevention in the 
EMS environment. This guide contains current 
information, recommendations, regulations, 
resources, program examples, and forms to utilize in 
the EMS system responder setting. 

Key concepts 

• Infection preventionists (IPs) are 
healthcare professionals who have special 
training in infection prevention and 
monitoring. 

• Many of the principles and practices 
that hospital IPs employ for infection 
prevention can and should be used 
in EMS settings, whether it be a fire 
department, police agency, or public or 
private ambulance company. 

• EMS system responders are exposed to all 
manners of infectious diseases and must 
be trained to recognize them and prevent 
their spread. 

• Designated Infection Control Officers 
(DICOs) are healthcare professionals 
who work for EMS agencies, have special 
training, and serve as their agencies’ 

IP. Federal law requires agencies have a 
designated DICO. 

• The DICO must be up to the challenging 
tasks of keeping current on infection 
prevention topics, conducting ongoing 
research, and updating procedures and 
policies as necessary. 


• Although compliance with infection 
prevention standards may seem complex, 
this guide will attempt to simplify the 
process and explain why utilizing the 
guide is the key to a safe workplace. 

• EMS leadership must support infection 
prevention staff and the development 
of infection prevention programs in 
compliance with laws and regulations. 
Leadership support is critical to successful 
implementation of basic infection 
prevention strategies. 

Infection prevention 

Created in hospitals and clinics, infection 
prevention training has by necessity expanded 
to include EMS system responders and out- 
of-hospital emergency medical care agencies. 
Infection prevention programs are designed to 
prevent the transmission of infectious disease 
agents and to provide a safe work environment for 
healthcare personnel and their patients. 

Infection prevention programs both inside and 
outside the hospital setting should contain six 
major components: 

• Administrative controls 

• Engineering controls 

• Work practice controls 

• Education 

• Medical management 

• Vaccine/immunization program 

These components will be discussed later in the 
guide. 


Association for Professionals in Infection Control and Epidemiology 9 




Guide to Infection Prevention in Emergency Medical Services 


Although there are articles, references, and 
guides available on infection prevention in 
EMS, infection prevention is limited because 
the expertise and resources are not present in 
many agencies. EMS agencies have known about 
bloodborne pathogens for years. However, it has 
only been in the last 5 to 6 years that articles 
describing methicillin-resistant Staphylococcus 
aureus (MRSA) in ambulances and fire stations 
have appeared in fire and EMS literature along 
with ways to prevent exposures. Two studies found 
in the American Journal of Infection Control address 
the transmission and carriage of MRSA within 
the fire department and ambulance environments. 
The University of Washington Department of 
Environmental and Occupational Health Services 
stated that fire and ambulance personnel have 
the unique opportunity to acquire and transfer 
infections from both hospital and community 
sources. 1 James V. Rago, PhD, and his team from 
Lewis University and Orland Fire Protection 
District, found that 70 percent of ambulances in 
the Chicago metropolitan area contained at least 
one strain of S. aureus bacteria. 2 

Infection prevention in the public safety sector 
is challenging. Because the scope of public safety 
members’ duties has expanded, there is an increased 
need to develop awareness and education. 

In most states, police agencies fall under the 
Occupational Safety & Health Administration 
(OSHA), Ryan White Notification Law, and 
infection prevention umbrella like other EMS 
system responders. However, they often have less 
training and minimal or no personal protective 
equipment (PPE) when they respond to a medical 
emergency or when they encounter a person with 
open wounds, blood, or infectious diseases. 

The National Institute for Occupational Safety 
and Health (NIOSH) completed national surveys 
that reveal a high incidence of exposures to 
bloodborne pathogens for paramedics. 3 Recent 
articles discuss the underreporting of exposures, 
the lack of safety equipment, the lack of PPE, and 
the lack of training in the use of PPE. 3 


This guide contains standards and regulatory 
information along with easy-to-follow templates 
and forms that can be used to develop an Exposure 
Control Plan and conduct infectious disease 
surveillance, risk assessments, and postexposure 
management, as well as monitor compliance. 

The treatment of exposures and injuries for EMS 
system responders has expanded significantly 
with the institution of occupational doctors, 
health nurses, safety chiefs, and other DICOs to 
oversee personnel health services. These groups 
have developed alliances with local hospitals and 
county health departments to ensure appropriate 
postexposure follow-up. They ensure exposures are 
handled within accepted treatment guidelines. 

Unfortunately, many departments, counties, and 
states do not have the funding needed for education 
and training in infection prevention. Some 
municipal hospitals provide this service and training 
free to EMS, police, and fire agencies. This guide has 
included some resources and websites that provide 
courses, online training, sample programs, and other 
information regarding infection prevention. 

EMS system responders are prepared for 
disasters and bioterrorism to varying degrees, 
but are largely dependent on the available 
resources and expertise within their EMS 
agencies. Larger municipal, metropolitan, and 
regional systems are often perceived as more 
prepared to deal with disaster and bioterrorism 
situations. Although there is increased 
awareness of bioterrorism incidents throughout 
the United States since September 11, 2001, 
no one can be truly prepared for all the hazards 
they could encounter during a bioterrorism 
event. This guide provides an overall view of the 
types of major biological weapons that might be 
encountered, types of PPE, and ways to protect 
one’s self and others. 

Although EMS system responders acknowledge 
the importance of protocols for cleaning and 
disinfecting equipment, several articles in 
EMS trade journals cite contamination of fire 


10 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


stations, ambulances, and equipment, such as 
with MRSA. 4,5 OSHA compliance monitoring 
requirements are presented later in the guide. 

The major goal of this guide is to increase 
awareness, educate, and provide guidance to 
EMS system responders who are at risk for 
occupational exposure to blood, other potentially 
infectious materials, infectious diseases, and 
bioterrorism. Standard EMS training curriculum 
contains information on infection prevention. 
However, EMS needs more integration with other 
community IPs and more efficient communication 
networks for information sharing. It is our 
sincere hope that this guide helps ensure a safer 
environment for both EMS system responders and 
the patients they care for in the community. 

Cited References 

1 Roberts MC, Soge OO, No D, Beck NK, Meschke 
JS. Isolation and characterizations of methicillin- 
resistant Staphylococcus aureus (MRSA) from fire 
stations in two northwest fire districts. Am J Infect 
Control 2Q\\ Jun;39(5):382-389. 


2 Rago RV, Buhs K, Makarovaite V, Patel E, Pomeroy M, 
Yasmine C. Detection and analysis of Staphylococcus aureus 
isolates found in ambulances in the Chicago metropolitan 
area. Am J Infect Control2Q\2 Apr;40(3):201-205. 

3 Centers for Disease Control and Prevention. 
Preventing exposures to bloodhorne pathogens among 
paramedics. April 2010. Available at: http://www.cdc. 
gov/niosh/docs/wp-solutions/2010-139/. Accessed 
December 6, 2012. 

4 Merlin AM, Wong ML, Pryor PW, Ryan K, Marques- 
Baptista A, Perritt R, et al. Presence of methicillin- 
resistant Staphylococcus aureus on the stethoscopes of EMS 
providers. Prehosp Emerg Care 2009 Jan-Mar; 13(l):71-74. 

5 Roline CE, Rumpecker C, Dunn TM. Can 
methicillin resistant Staphylococcus aureus be found in 
an ambulance fleet? Prehosp Emerg Care 2007 Apr- 
June;ll(2):24l-243. 


Association for Professionals in Infection Control and Epidemiology 11 



Guide to Infection Prevention in Emergency Medical Services 


Section 2: Epidemiology and 
Pathogenesis: Infectious Diseases in EMS 


Key concepts 

• Effective efforts to eliminate or reduce 
bloodborne and infectious disease 
exposures and transmission are guided by 
the epidemiology (causes and distribution) 
of those diseases. 

• Communicable diseases can be passed 
from one person to another. Infectious 
disease can cause illness in a person but is 
not necessarily communicable. 

• The current infectious disease burden 
for the agency and setting is found 
by conducting an environmental risk 
assessment. 

• EMS agencies must ensure all EMS 
system responders report to work healthy. 
They must have a written plan in place 
outlining work restriction guidelines when 
EMS system responders contract and/or 
are exposed to an infectious disease. 

• EMS agencies must ensure all EMS 
system responders have the necessary 
immunizations or written proof of 
immunity to protect them against 
infectious diseases. 

Background 

Epidemiology is defined as the study of the 
distribution and determinants of health- 
related states in specified populations, and 
the application of this study to control health 
problems. 1 Epidemiology includes outbreak 
investigation, disease surveillance, and 


screening and comparison of treatment effects. 
Pathogenesis of a disease is the mechanism by 
which the disease is caused. 

The Centers for Disease Control and Prevention 
(CDC), through the Ryan White Act, is charged 
with keeping a list of potentially life-threatening 
diseases that must be reported by medical facilities 
to EMS agencies when one of those diseases is 
found in a patient transported to their facility. 

This list reflects diseases that have been around 
for many years and diseases that have recently re- 
emerged (see Table 2.1). EMS agencies should also 
be aware of nonreportable diseases that threaten 
their workforce. 

In the Guideline for Infection Control in 
Health Care Personnel 1998, the CDC 
recognized EMS system responders as 
being at risk for acquiring infections from 
or transmitting infections to patients, 
other personnel, household members, or 
other community contacts. 2 The DICO or 
personnel health services should arrange for 
the prompt diagnosis of job-related illnesses 
and postexposure prophylaxis after job-related 
exposures. Decisions on work restrictions 
are based on mode of transmission and 
epidemiology of the disease (Table 2.2). 
Exclusion policies should contain a statement of 
authority defining who can exclude personnel 
and should be designed to encourage personnel 
to report their illnesses or exposures without 
penalizing them with loss of wages, benefits, or 
job status. 


12 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Table 2.1. List of potentially life-threatening infectious diseases to which emergency response 
employees may be exposed 


Diseases routinely 
transmitted by contact or 
body fluid exposures 

Diseases routinely 
transmitted through 
aerosolized airborne 

means 

Diseases routinely 
transmitted through 
aerosolized droplet means 

Diseases caused by agents 
potentially used for 
bioterrorism or biological 
warfare 

Anthrax, cutaneous 
(.Bacillus anthracis ) 

Measles (Rubeola virus) 

Diphtheria 
(Corynebacterium 
diphtheriae ) 

These diseases include those 
caused by any transmissible 
agent included in the HHS 
Select Agents List 

Hepatitis B (HBV) 

Tuberculosis 
(.Mycobacterium 
tubercidosis )—infectious 
pulmonary or laryngeal 
disease; or extrapulmonary 
(draining lesion) 

Novel influenza A viruses 
as defined by the Council 
of State and Territorial 
Epidemiologists (CSTE) 


Hepatitis C (HCV) 

Varicella disease ( Varicella 
zoster virus)—chickenpox, 
disseminated zoster 

Meningococcal disease 
(Neisseria meningitidis ) 


Human immunodeficiency 
virus (HIV) 


Mumps (Mumps virus) 


Rabies (Rabies virus) 


Pertussis ( Bordetella 
pertussis) 


Vaccinia (Vaccinia virus) 


Plague, pneumonic 
(Yersinia pestis) 


Viral hemorrhagic fevers 
(Lassa, Marburg, Ebola, 
Crimean-Congo, and 
other viruses yet to be 
identified) 


Rubella (German measles; 
Rubella virus) 




SARS-CoV 



Adapted from National Institute for Occupational Safety and Health. List of potential life-threatening diseases. 3 


Table 2.2. Summary of suggested work restrictions for healthcare personnel exposed to or 
infected with infectious diseases of importance in healthcare settings, in the absence of state 
and local regulations 


Disease/problem 

Work restriction 

Duration 

Category 

Conjunctivitis 

Restrict from patient contact 
and contact with the patient’s 
environment 

Until discharge ceases 

II 

Cytomegalovirus infections 

No restriction 


I 

Diarrheal diseases 

Acute stage (diarrhea with 
other symptoms) 

Restrict from patient contact, contact 
with the patient's environment, or 
food handling 

Until symptoms resolve 

I 

IB 


(continued) 


Association for Professionals in Infection Control and Epidemiology 13 























Guide to Infection Prevention in Emergency Medical Services 


Table 2.2. Summary of suggested work restrictions for healthcare personnel exposed to or 
infected with infectious diseases of importance in healthcare settings, in the absence of state 
and local regulations, continued 


Disease/problem 

Work restriction 

Duration 

Category 

Convalescent stage, 
Salmonella spp. 

Restrict from care of high-risk 
patients 

Until symptoms resolve; 
consult with local and state 
health authorities regarding 
need for negative stool cultures 

IB 

Diphtheria 

Exclude from duty 

Until antimicrobial therapy 
completed and 2 cultures 
obtained 24 hours apart are 
negative 

IB 

Enteroviral infections 

Restrict from care of infants, 
neonates, and immunocompromised 
patients and their environments 

Until symptoms resolve 

II 

Hepatitis A 

Restrict from patient contact, contact 
with patient’s environment, and food 
handling 

Until 7 days after onset of 
jaundice 

IB 

Hepatitis B 

Personnel with acute or 
chronic hepatitis B surface 
antigemia who do not 
perform exposure-prone 
procedures 

No restriction; refer to state 
regulations; Standard Precautions 
should always be observed 



Personnel with acute or 
chronic hepatitis B e anti- 
genemia who perform 
exposure-prone procedures 

Do not perform exposure-prone 
invasive procedures until counsel 
from an expert review panel has been 
sought; panel should review and 
recommend procedures the worker can 
perform, taking into account specific 
procedure as well as skill and technique 
of worker; refer to state regulations 

Until hepatitis B e antigen is 
negative 

II 

Hepatitis C 

Restrict only from Class III procedures 


II 

Herpes simplex 

Genital 

Hands (herpetic whitlow) 

No restriction 

Restrict from patient contact and contact 
with the patient’s environment 

Until lesions heal 

II 

IA 

Orofacial 

Evaluate for need to restrict from care 
of high-risk patients 



Human immunodeficiency 
virus 

Do not perform exposure-prone 
invasive procedures until counsel 
from an expert review panel has 
been sought; panel should review 
and recommend procedures the 
worker can perform, taking into 
account specific procedure as well as 
skill and technique of the worker; 
standard precautions should always be 
observed; refer to state regulations 




(continued) 


14 Association for Professionals in Infection Control and Epidemiology 
















Guide to Infection Prevention in Emergency Medical Services 


Table 2.2. Summary of suggested work restrictions for healthcare personnel exposed to or 
infected with infectious diseases of importance in healthcare settings, in the absence of state 
and local regulations, continued 


Disease/problem 

Work restriction 

Duration 

Category 

Measles 

Active 

Exclude from duty 

Until 7 days after the rash 
appears 

IA 

Postexposure (susceptible 
personnel) 

Exclude from duty 

From 5 th day after 1st 
exposure through 21st day 
after last exposure and/or 4 
days after rash appears 

IB 

Meningococcal infections 

Exclude from duty 

Until 24 hours after start of 
effective therapy 

IA 

Mumps 

Active 

Exclude from duty 

Until 9 days after onset of 
parotitis 

IB 

Postexposure (susceptible 
personnel) 

Exclude from duty 

From 12th day after 1st 
exposure through 26th day 
after last exposure or until 9 
days after onset of parotitis 

II 

Pertussis 

Active 

Exclude from duty 

From beginning of catarrhal 
stage through 3rd wk after 
onset paroxysms or until 5 
days after start of effective 
antimicrobial therapy 

IB 

Postexposure 
(asymptomatic personnel) 

No restriction; prophylaxis 
recommended 


I 

Postexposure 
(symptomatic personnel) 

Exclude from duty 

Until 5 days after start of 
effective antimicrobial therapy 

IB 

Rubella 

Active 

Exclude from duty 

Until 5 days after rash appears 

IA 

Postexposure (susceptible 
personnel) 

Exclude from duty 

From 7th day after 1st 
exposure through 21st day 
after last exposure 

IB 

Scabies 

Restrict from patient contact 

Until cleared by medical 
evaluation 

IB 

Staphylococcus aureus 
Infection 

Active, draining skin 
lesions 

Restrict from contact with patients and 
patient’s environment or food handling 

Until lesions have resolved 

IB 

Carrier state 

No restriction, unless personnel 
are epidemiologically linked to 
transmission of the organism 


IB 


(continued) 


Association for Professionals in Infection Control and Epidemiology 15 
















Guide to Infection Prevention in Emergency Medical Services 


Table 2.2. Summary of suggested work restrictions for healthcare personnel exposed to or 
infected with infectious diseases of importance in healthcare settings, in the absence of state 
and local regulations, continued 


Disease/problem 

Work restriction 

Duration 

Category 

Streptococcal infection, 
group A 

Restrict from patient care, contact with 
patient’s environment, or food handling 

Until 24 hours after adequate 
treatment started 

IB 

Tuberculosis 

Active disease 

PPD converter 

Exclude from duty 

No restriction 

Until proved noninfectious 

IA 

IA 

Varicella 

Active 

Exclude from duty 

Until all lesions dry and crust 

IA 

Postexposure (susceptible 
Personnel) 

Exclude from duty 

From 10th day after 1st 
exposure through 21st day 
(28th day if VZIG given) 
after last exposure 

IA 

Zoster 

Localized, in healthy 
person 

Cover lesions; restrict from care of 
high-risk patientsf 

Until all lesions dry and crust 

II 

Generalized or localized in 
immunosuppressed person 

Restrict from patient contact 

Until all lesions dry and crust 

IB 

Postexposure (susceptible 
personnel) 

Restrict from patient contact 

From 10th day after 1st 
exposure through 21st day 
(28th day if VZIG given) 
after last day exposure or, 
if Varicella occurs, until all 
lesions dry and crust 

IA 

Viral respiratory infections, 
acute febrile 

Consider excluding from the care of 
high-risk patients^ or contact with 
their environment during community 
outbreak of RS V and influenza 

Until acute symptoms resolve 

IB 


*Unless epidemiologically linked to transmission of infection 

fThose susceptible to varicella and who are at increased risk of complications of varicella, such as neonates and immuno¬ 
compromised persons of any age. 

$ High-risk patients as defined by the ACIP for complications of influenza. 

As in previous CDC guidelines, each recommendation is categorized on the basis of existing scientific data, theoretic 
rationale, applicability, and potential economic impact. The system for categorizing recommendations is as follows: 
Category IA - Strongly recommended for all hospitals and strongly supported by well-designed experimental or epide¬ 
miologic studies. 

Category IB - Strongly recommended for all hospitals and reviewed as effective by experts in the field and a consensus 
of Hospital Infection Control Practices Advisory Committee members on the basis of strong rationale and suggestive 
evidence, even though definitive scientific studies have not been done. 

Category II - Suggested for implementation in many hospitals. Recommendations may be supported by suggestive clini¬ 
cal or epidemiologic studies, a strong theoretic rationale, or definitive studies applicable to some but not all hospitals. 

No recommendation; unresolved issue - Practices for which insufficient evidence or consensus regarding efficacy exists. 
Source: Bolyard EA, Tablan OC, Williams WW, Pearson ML, Shapiro CN,Deitchman SD, et al. Guideline for infection 
control in healthcare personnel, 1998. Centers for Disease Control and Prevention. Available at: www.cdc.gov/hicpac/ 
pdf/InfectControl9 8. pdf 


16 Association for Professionals in Infection Control and Epidemiology 













Guide to Infection Prevention in Emergency Medical Services 


Immunization programs 

Ensuring that personnel are immunized against 
vaccine-preventable diseases is an essential part 
of successful personnel health programs, and 
OSHA is enforcing the CDC immunization 
guidelines (Table 2.3). Immunization can prevent 
transmission of vaccine-preventable diseases and 
eliminate unnecessary work restriction. Prevention 
of illness through comprehensive personnel 
immunization programs is far more cost-effective 
than case management, outbreak control, sick 
leave, and replacement costs. 

Decisions about vaccines to include in 
immunization programs have been made by 
considering the following: 

(a) The likelihood of personnel exposure 
to vaccine-preventable diseases and the 
potential consequences of not vaccinating 
personnel 

(b) The nature of employment (type 
of contact with patients and their 
environment) 

(c) The characteristics of the patient 
population within the healthcare 
organization 

(d) Nationally accepted standards such 
as NFPA 1581 (NFPA 1581, Standard 
on Fire Department Infection Control 
Program) and 1582 (Standard on 
Comprehensive Occupational Medical 
Program for Fire Departments). 

Example of epidemiology, 
pathogenesis, and transmission 

Staphylococcus aureus is found on the skin of humans 
as part of our normal body flora. It is estimated 
that nasal colonization in the general U.S. adult 
population is 25 to 30 percent. 4 S. aureus from nasal 
colonization can be transferred to skin and other 
body areas. An infection occurs when a breach in 
the skin allows staph bacteria to enter. Methicillin- 


resistant S. aureus (MRSA) is a strain of staph 
bacteria that is resistant to 8-lactam antibiotics. 

Until the late 1990s MRSA was predominately 
found in hospitals. However, starting in the 
late 1990s, MRSA infections were increasingly 
found in populations with no known healthcare- 
associated risks for acquisition. 5 These cases were 
labeled community-acquired MRSA (CA-MRSA). 
According to the International Association of Fire 
Fighters, MRSA is considered a serious threat to 
EMS system responders. 6 Because EMS system 
responders bridge the community and healthcare 
settings, they are at high risk for contracting and 
transmitting MRSA. 

Although hospital-associated MRSA infections 
are tracked, most EMS agencies do not have the 
processes in place to track cases of CA-MRSA. 

In order to implement interventions to reduce 
or eliminate MRSA, total number of cases each 
year should be tracked along with all associated 
medical costs. 

Strategies to prevent 
transmission of MRSA and 
other infectious diseases 

Documentation shows MRSA transmission both 
directly from infected and colonized patients 
and indirectly via contaminated equipment, 
supplies, and environmental surfaces. Standard 
Precautions is the first step in prevention, as is 
identification of common transmission routes. 
When the sources of transmission are identified, 
infection prevention staff or the DICO should 
implement a series of focused interventions 
including the following: 

• Education in infection prevention 

• Proper and frequent use of disinfectants 

• Hand hygiene and the appropriate use of 
gloves 

• Replacement of cloth surfaces with hard 
surfaces 


Association for Professionals in Infection Control and Epidemiology 17 



18 Association for Professionals in Infection Control and Epidemiology 


Table 2.3. Immunobiologies and schedules and immunizing agents strongly recommended for healthcare personnel 


Generic name 

Primary booster dose 
schedule 

Indications 

Major precautions and 
contraindications 

Special considerations 

Hepatitis B recombinant 
vaccine 

Two doses IM in the 
deltoid muscle 4 weeks 
apart; third dose 5 
months after second; 
booster doses not 
necessary 

Healthcare personnel at risk of 
exposure to blood and body fluids 

No apparent adverse effects 
to developing fetuses, not 
contraindicated in pregnancy; 
history of anaphylactic reaction to 
common baker’s yeast 

No therapeutic or adverse effects 
on HBV-infected persons; cost- 
effectiveness of prevaccination 
screening for susceptibility 
to HBV depends on costs of 
vaccination and antibody testing 
and prevalence of immunity in 
the group of potential vaccines; 
healthcare personnel who have 
ongoing contact with patients 
or blood should be tested 1-2 
months after completing the 
vaccinations series to determine 
serologic response 

Influenza vaccine 
(inactivated whole or 
split virus) 

Annual single-dose 
vaccination IM with 
current (either whole or 
split-virus) vaccine 

Healthcare personnel with contact 
with high-risk patients or working 
in chronic care facilities; personnel 
with high-risk medical conditions 
and/or >65 years 

History of anaphylactic 
hypersensitivity after egg ingestion 

No evidence of maternal or fetal 
risk when vaccine was given to 
pregnant women with underlying 
conditions that render them at 
high risk for serious influenza 
complications 

Measles live-virus 
vaccine 

One dose SC; second 
dose at least 1 month 
later 

Healthcare personnel born in or 
after 1957 without documentation 
of (a) receipt of two doses of 
live vaccine on or after their first 
birthday, (b) physician-diagnosed 
measles, or (c) laboratory evidence 
of immunity; vaccine should 
be considered for all personnel, 
including those born before 1957, 
who have no proof of immunity 

Pregnancy; immunocompromised* 
state; (including HIV- 
infected) persons with severe 
immunosuppression) history of 
anaphylactic reactions after gelatin 
ingestions or receipt of neomycin; 
or recent receipt of immune 
globulin 

MMR is the vaccine of choice 
if recipients are also likely to 
be susceptible to rubella and/ 
or mumps; persons vaccinated 
between 1963 and 1967 with (a) 
a killed measles vaccine alone, 

(b) killed vaccine followed by 
live vaccine, or (c) a vaccine 
of unknown type should be 
revaccinated with two doses of live 
measles vaccine 


Guide to Infection Prevention in Emergency Medical Services 












Association for Professionals in Infection Control and Epidemiology 19 


Table 2.3. Immunobiologies and schedules and immunizing agents strongly recommended for healthcare personnel, continued 


Generic name 

Primary booster dose 
schedule 

Indications 

Major precautions and 
contraindications 

Special considerations 

Mumps live-virus 
vaccine 

One dose SC; no booster 

Healthcare personnel believed to 
be susceptible can be vaccinated; 
adults born before 1957 can be 
considered immune 

Pregnancy; immunocompromised* 
state; history of anaphylactic 
reactions after gelatin ingestions or 
receipt of neomycin 

Women pregnant when vaccinated 
or who become pregnant within 3 
months of vaccination should be 
counseled on the theoretic risks 
to the fetus, the risk of rubella 
vaccine-associated malformations 
in these women is negligible; 

MMR is the vaccine of choice 
if recipients are also likely to be 
susceptible to measles or mumps 

Rubella live- 
virus vaccine 

One dose SC; 
no booster 

Healthcare personnel, both 
male and female, who lack 
documentation of receipt of live 
vaccine on or after their first 
birthday, or of laboratory evidence 
of immunity; adults born before 
1957 can be considered immune, 
except women of childbearing age 

Pregnancy; immunocompromised* 
state; history of anaphylactic 
reaction after receipt of neomycin 

Women pregnant when vaccinated 
or who become pregnant within 3 
months of vaccination should be 
counseled on theoretic risks to the 
fetus, the risk of rubella vaccine- 
associated malformations in these 
women in negligible; MMR is 
the vaccine of choice if recipients 
are also likely to be susceptible to 
measles or mumps 

Varicella zoster live-virus 
vaccine 

Two 0.5 mL doses SC, 

4-8 weeks apart if >13 
years 

Healthcare personnel without 
reliable history of varicella or 
laboratory evidence of varicella 
immunity 

Pregnancy, immunocompromised* 
state, history of anaphylactic 
reaction after receipt of neomycin 
or gelatin; salicylate use should 
be avoided for 6 weeks after 
vaccination 

Because 71%—93% of persons 
without a history of varicella are 
immune, serologic testing before 
vaccination may be cost-effective 


IM, Intramuscular; SC, subcutaneously. 

^Persons immunocompromised because of immune deficiencies, HIV infection, leukemia, lymphoma, generalized malignancy, or immunosuppressive therapy 
with corticosteroids, alkylating drugs, antimetabolites, or radiation. 

Source: Bolyard EA, Tablan OC, Williams WW, Pearson ML, Shapiro CN,Deitchman SD, et al. Guideline for infection control in healthcare personnel, 
1998. Centers for Disease Control and Prevention. Available at: www.cdc.gov/hicpac/pdf/InfectControl98.pdf. Accessed January 24, 2013. 


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Guide to Infection Prevention in Emergency Medical Services 


• Confinement of turnout gear to work Contact Precautions for MRSA 

areas patients 

• Station wear kept at the station and 

laundered after use. In addition to Standard Precautions described, 

CDC recommends using Contact Precautions if 

In addition, EMS system responders should use a patient is known to be colonized with MRSA 

Standard Precautions as described below in Table or has an active MRSA infection. In general, 

2.4 to prevent transmission of MRSA and other Contact Precautions will be applied once the 
multidrug-resistant organisms. patient is admitted to the hospital. However, 

Table 2.4. Recommendations for application of standard precautions for the care of all 
patients in all healthcare settings 7 


Component 

Recommendations 

Hand hygiene 

After touching blood, body fluids, secretions, excretions, 
contaminated items; immediately after removing gloves; between 
patient contacts 

Personal protective equipment (PPE) 


Gloves 

For touching blood, body fluids, secretions, excretions, contaminated 
items; for touching mucous membranes and nonintact skin 

Gown 

During procedures and patient-care activities when contact of 
clothing/exposed skin with blood/body fluids, secretions, and 
excretions is anticipated 

Mask, eye protection (goggles), face shield* 

During procedures and patient-care activities likely to generate 
splashes or sprays of blood, body fluids, secretions, especially 
suctioning, endotracheal intubation 

Soiled patient-care equipment 

Handle in a manner that prevents transfer of microorganisms to 
others and to the environment; wear gloves if visibly contaminated; 
perform hand hygiene 

Environmental control 

Develop procedures for routine care, cleaning, and disinfection of 
environmental surfaces, especially frequently touched surfaces in 
patient-care areas 

Textiles and laundry 

Handle in a manner that prevents transfer of microorganisms to 
others and to the environment 

Needles and other sharps 

Do not recap, bend, break, or hand-manipulate used needles; if 
recapping is required, use a one-handed scoop technique only; use 
safety features when available; place used sharps in puncture-resistant 
container 

Patient resuscitation 

Use mouthpiece, resuscitation bag, other ventilation devices to 
prevent contact with mouth and oral secretions 

Patient placement 

Prioritize for single-patient room if patient is at increased risk of 
transmission, is likely to contaminate the environment, does not 
maintain appropriate hygiene, or is at increased risk of acquiring 
infection or developing adverse outcome following infection 


(continued) 


20 Association for Professionals in Infection Control and Epidemiology 


















Guide to Infection Prevention in Emergency Medical Services 


Table 2.4. Recommendations for application of standard precautions for the care of all 
patients in all healthcare settings 7 , continued 


Component 

Recommendations 

Respiratory hygiene/cough etiquette 

(source containment of infectious respiratory 
secretions in symptomatic patients, beginning 
at initial point of encounter; e.g., triage and 
reception areas in emergency departments and 
physician offices) 

Instruct symptomatic persons to cover mouth/nose when sneezing/ 
coughing; use tissues and dispose in no-touch receptacle; observe 
hand hygiene after soiling of hands with respiratory secretions; wear 
surgical mask if tolerated or maintain spatial separation, >3 feet if 
possible. 


* During aerosol-generating procedures on patients with suspected or proven infections transmitted by respiratory aero¬ 
sols (e.g., SARS), wear a fit-tested N95 or higher respirator in addition to gloves, gown, and face/eye protection. As part 
of respiratory etiquette, EMS system responders are advised to wear an approved mask or respirator and eye protection 
when examining and caring for patients with signs and symptoms of a respiratory infection. More detailed information 
on masks is provided in the Work Practice Controls and Personal Protective Equipment (PPE) section later in the guide. 


EMS system responders can adapt elements 
of these precautions to prevent contracting or 
transmitting MRSA prior to the patient’s arrival 
to the hospital, particularly in cases in which 
patients have draining wounds or difficulty 


controlling body fluids. Table 2.5 describes the 
basic components of Contact Precautions with 
some adaptions made for the EMS 
environment. 


Table 2.5. Basic components of Contact Precautions 


Component 

Recommendations 

Patient transport 

Ensure infected or colonized areas of the patient’s body are covered and 
contained; don clean PPE and perform hand hygiene prior to transporting 
patient and again when handling the patient upon arrival to transport 
destination 

Gloves 

For touching intact skin or surfaces and articles in close proximity to the 
patient 

Gown 

For interactions with the patient or in the patient care environment that may 
result in contamination of clothing or environment outside of the area of 
patient care; gowns should be disposed and hand hygiene performed prior to 
leaving the patient care environment, ensuring that clothing and skin do not 
come in contact with contaminated surfaces 

Patient care equipment 

When possible, use dedicated noncritical patient care equipment; ensure any 
nondedicated equipment is properly cleaned and disinfected before use with 
another patient 

Environmental control 

Develop procedures to ensure cleaning and disinfection of high-touch surfaces 
and areas in close proximity to patient on Contact Precautions 

Patient placement 

(Upon arrival at hospital) Single patient room, if available, or cohorting with 
other patients who have MRSA or who have low risk of acquiring or suffering 
adverse effects of a MRSA infection 


Adapted from: Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory 
Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 
2007. Available at: http://www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html. Accessed January 24, 2013. 


Association for Professionals in Infection Control and Epidemiology 21 















Guide to Infection Prevention in Emergency Medical Services 


Cited References 

1 Centers for Disease Control and Prevention. 

An introduction to epidemiology. 2004. Available 
at: www.cdc.gov/excite/classroom/intro_epi.htm. 
Accessed January 24, 2013. 

2 Sepkowitz KA. Occupationally acquired infections 
in health care workers. Part I and II. Ann Intern Med 
1996; 125:826-834/917-928. 

3 Implementation of Section 2695 (42 USC 300ff- 
131) of Public Law 111-87: Infectious Diseases and 
Circumstances Relevant to Notification Requirements. 
Federal Register Nov 2 2011;76(212). Available at: 
http://www.cdc.gov/niosh/topics/ryanwhite/pdfs/ 

FRN11-2-201 lGPO.pdf. Accessed January 24, 2013. 

4 Centers for Disease Control and Prevention. MRSA 
and the workplace. 2011. Available at: www.cdc.gov/ 
niosh/topics/mrsa. Accessed January 24, 2013. 

5 Aureden K, Arias K, Burns L, Creen, C, Hickok J, 
Moody J, et al. Guide to the elimination ofmethicillin- 
resistant Staphylococcus aureus (MRSA) transmission 
in hospital settings, 2nd ed. Washington, DC: Roche, 
2010 ; 8 . 

6 Williams D. Danger in the station: drug resistant 
infections. Fire Engineering 2006;159:69-74. 


7 The CDC Healthcare Infection Control Practices 
Advisory Committee. 2007 Guideline for Isolation 
Precautions: Preventing Transmission of Infectious Agents 
in Healthcare Settings. Available at: http://www.cdc. 
gov/hicpac/2007IP/2007isolationPrecautions.html. 
Accessed January 24, 2013. 

Additional Resources 

Centers for Disease Control and Prevention. List of 
potentially life-threatening infectious diseases to which 
emergency response employees may be exposed. Federal 
Register Dec 2 2011;76(212). 

NFPA 1581, Standard on Fire Department Infection 
Control Program, 2005. 

NFPA 1582, Standard on Comprehensive 
Occupational Medical Program for Fire Departments, 
2007. 

Ryan White HIV/AIDS treatment extension act of 
2009. Available at: http://www.cdc.gov/niosh/topics/ 
ryanwhite/. Accessed December 13, 2012. 

CDC Select Agent Program. Available at: http://www. 
cdc.gov/phpr/documents/DSAT_brochure_J uly2011. 
pdf. Accessed December 13, 2012. 


22 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Section 3: Risk Factors/Risk Assessment 
in EMS 


Purpose 

Awareness of hazards is an important part of 
protecting EMS system responders. Agencies 
can perform a hazard risk assessment to obtain a 
baseline incidence, prevalence, and transmission of 
hazards. These include exposure to communicable 
diseases, hazardous materials, and sharps-related 
injuries. The hazard risk assessment guides 
development of a surveillance, prevention, and 
infection control program. 

Key concepts 

• Past and current agency-specific 
surveillance data is the focus of the risk 
assessment. 

• Exposure and injury surveillance data 
includes demographic, geographic, and 
published EMS/Fire/Public Safety data 
on risk. 

• Risk assessment should be continuously 
revised or updated when there is a change 
based on ongoing surveillance, when 
populations change, or when additional 
risks are identified. 

• Information from the risk assessment 
drives education and improvement 
processes. Epidemiology is the foundation 
of the process. 

Background 

EMS system responders face a wide variety of 
serious hazards due to the unpredictable nature of 
their jobs. There are exposure and injury risks at 
motor vehicle accidents, fires, hazardous materials 
(hazmat) incidents, and mass casualty incidents to 


name a few. EMS system responders are routinely 
exposed to situations that threaten their personal 
safety, including exposures to infectious diseases, 
hazardous materials, and sharps-related injuries. 
They may encounter combative patients, patients 
with infectious diseases, traumatic injuries, and 
exposure to chemical, biological, radiological 
agents, and exposures related to bioterrorism. 

There are many federal, state, and local practice 
standards, resources, and expert guidance to 
assist agencies with infection prevention plans. 
Agencies must also develop a tracking system to 
monitor exposure and injury trends. Monitoring 
trends over time will show whether incidences 
of exposures and sharps-related injury rates are 
decreasing or whether additional actions need to 
be taken if rates are increasing. Comparison with 
baseline measurements and analysis will determine 
the need for an intervention and determine the 
appropriate intervention. Continued monitoring 
is needed to reassess the effectiveness of the 
interventions. 

If available, past and current agency surveillance 
data is the core of the risk assessment. 

Agencies can obtain relevant infectious disease 
surveillance data from local and state public 
health departments. Agencies should monitor 
community and population-specific risk factors 
and epidemiology for the following diseases: 

• Tuberculosis 

• HIV/AIDS 

• Hepatitis C 

• Influenza 

• MRSA 


Association for Professionals in Infection Control and Epidemiology 23 



Guide to Infection Prevention in Emergency Medical Services 


• Other emerging multidrug-resistant 
organisms (MDROs) 

• Other diseases on the CDC list of 
reportable diseases (see Table 2.1) 

In addition, each DICO should be aware of their 
state’s specific regulations (i.e., California 5199) 
for disease monitoring and reporting. 

Infectious disease and sharps 
injury risk factors 

General risk factors for infectious diseases and 
sharps-related injuries are well documented in 
medical literature. Known risk factors include, but 
are not limited to: 

• Exposure to patients with chronic diseases 
(HIV, hepatitis B and C) 

• Exposure to blood and other potentially 
infectious fluids 

• Exposure to patients with infectious 
diseases (MRSA, meningitis, influenza) 

• Failure to use engineering controls such as 
self-sheathing IV catheters and needleless 
systems 

• Failure to use appropriate sharps containers 

• High-risk procedures such as intubation, 
IV starts, and bandaging 

• Noncompliance with Standard Precautions 

• Poor hand washing techniques 

• Faulty, defective, or improperly used 
equipment 

• Lack of preventative immunizations 

• Failure to properly decontaminate 
equipment and other work surfaces 

• Poorly lit work area 

• Hazardous work areas including 
hazardous material or fire responses 

• Combative patients with obvious blood 
exposure 

• Inappropriate disposal of contaminated 
sharps 


Infectious diseases and sharps- 
related injuries risk assessment 
basics 

EMS system responders should use Standard 
Precautions for all patients. They should use 
additional PPE based on the risks they identify 
from the information they receive from dispatch 
or from their assessment when they arrive on the 
scene. Some agencies have the ability to identify 
patients with confirmed or suspected infectious 
diseases in dispatch information. However, given 
the mobile nature of society, agencies must be aware 
that the person at the address may not be the same 
as in agency records. EMS agencies must develop 
relationships with hospital IPs and local public health 
departments to develop a system for reporting and 
treating personnel with exposures. The ability to 
track infectious disease exposures and sharps-related 
injuries is essential for risk assessment. Standardized 
processes for capturing relevant data ensure that 
statistical evaluation is relevant and can be compared 
over time. The following is an example to illustrate 
risk assessment basics. 

The EMS exposure risk assessment requires the 
person responsible for tracking exposures (i.e., DICO, 
occupational health RN, IP) to do the following: 

Example 3.1. Utilizing exposure surveillance 
data for infectious diseases, airborne, bloodborne, 
hazmat, and sharps-related exposures when a risk 
assessment is conducted 


Description of exposures and action required are 
summarized in the table below. 


EXPOSURE 

DESCRIPTION 

ACTION 

REQUIRED 

Exposure of open 
skin, cuts, or breaks or 
mucous membranes, 
such as eyes, nose, 
or mouth, to blood 
or body fluids. This 
includes needlesticks 
and human bites. 

Clean exposed area; 
if in the mouth, rinse 
and spit; flush eyes as 
appropriate. Provide 
first aid if needed. Call 
your DICO. 


24 Association for Professionals in Infection Control and Epidemiology 








Guide to Infection Prevention in Emergency Medical Services 


Example 3.1. Annual Summary of Reported EMS Exposures 




Jan. 

Feb. 

Mar. 

Apr. 

May 

Jun. 

Jul. 

Aug. 

Sept. 

Oct. 

Nov. 

Dec. 

Total 


No. of exposures 

1 

0 

2 

4 

4 

4 

2 

4 

2 

7 

2 

3 

35 

Airborne 

Infectious 

0 

0 

1 

2 

2 

4 

1 

0 

1 

0 

1 

2 

14 

Hazmat 

1 

0 

0 

0 

0 

0 

0 

4 

0 

2 

0 

0 

7 

Bloodborne 

Needlestick 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

0 

0 

1 

Nonintact skin 

0 

0 

0 

1 

0 

0 

1 

0 

1 

2 

1 

0 

6 

Mucous 

membrane 

0 

0 

1 

0 

2 

0 

0 

0 

0 

3 

0 

1 

7 


• Establish baseline incidence and/or 
prevalence of exposures and injuries 
(agencies should look for the incidence 
rate tied to patient contacts; i.e., exposures 
per 1,000 patient contacts). 

• Identify high-risk employee practices 
or stations based on incident rates and 
identify clusters to determine if additional 
interventions may be needed. 

• Evaluate infectious disease transmission 
over time to characterize station-specific 
and disease-specific prevalence or 
transmission rates. 

• Track employee absenteeism to detect 
subtle variances in sick leave associated 
with specific stations, or shifts, to serve 
as an early sentinel to possible infectious 
disease implications. 

• Establish rates and ensure compliance 
with Standard Precautions and PPE use. 

• Focus data-driven interventions on stations/ 
employees with high exposure or injury rates. 

• Obtain employee input to improve 
infection control policies and procedures 
to maximize support and participation. 

• Identify gaps in knowledge for targeted 
educational interventions. 


• Ensure employees have annual exposure 
control plan training that allows enough 
time for feedback and questions. 

In the example provided, using infectious disease 
exposure surveillance data for the infectious 
disease assessment of the EMS system responders 
who had a reported exposure (number = 6), three 
were diagnosed and treated for MRSA. Since 
beginning to track MRSA-reported exposures, 
reporting has increased, although the total number 
of actual patients with MRSA is unknown because 
that information is not always given to the EMS 
system responder. The DICO investigated all 
reported MRSA-related exposure reports and 
determined only six patients had confirmed 
MRSA. Because of the Health Insurance 
Portability and Accountability Act (HIPAA) 
constraints, not all crews receive confidential 
patient medical information regarding their 
potential infectious disease status as part of the call 
read back from the dispatch center and hospitals 
do not always report back to the EMS system 
responders. 

EMS system responders submit an exposure report 
and document the disease they were exposed 
to during patient care (see Example 3.2). EMS 


Example 3.2. MRSA exposure report 


Year 

2003 

2004 

2005 

2006 

2007 

2008 

2009 

2010 

Number of Reported MRSA Exposures 

1 

5 

4 

9 

0 

12 

21 

24 


Association for Professionals in Infection Control and Epidemiology 25 





Guide to Infection Prevention in Emergency Medical Services 


system responders are required to document the 
type of PPE worn. EMS agencies can analyze their 
exposure data to evaluate MRSA-related exposures 
and MRSA illness transmission to EMS system 
responders. This type of analysis can be done 
to determine crews at high risk. Interventions 
and education can be introduced to decrease the 
number of EMS system responders diagnosed 
with MRSA. In the case above, EMS system 
responders were educated on MRSA to reduce 
their fear of the disease and educate them on the 
modes of transmission. 

MRSA assessment and 
intervention scenario 

As seen in Example 3.2, an upward trend of 
MRSA reported exposures and EMS system 
responders with MRSA led to increased 
multipronged educational interventions on how 
to reduce risk of contracting MRSA. This MRSA 
Awareness Program included: 

• An interactive, visual, fact-based 
awareness program to crews via closed 
circuit TV 

• Stories from actual EMS system 
responders (identities were kept 
confidential) who had contracted MRSA 

• A frequently asked questions memo sent 
out to all crews 

• CDC fact sheets sent to all crews to be 
posted at stations 

• Reminders to crews about hand washing 
and use of PPE 

• Reminders to crews to decontaminate 
all medical equipment and not to bring 
equipment into stations 

• Quick drills sent out every 6 months to 
remind crews about MRSA and ways to 
prevent it 

Agencies must continue to monitor for a 
reduction in MRSA-related infection rates 


among EMS responders once education and 
infection prevention interventions have been 
implemented. The DICO will then communicate 
the results of MRSA surveillance to all 
employees. Employees can also be monitored for 
compliance with hand hygiene, use of PPE, and 
environmental and equipment decontamination. 
Although MRSA continues to be a problem in 
the United States, significant progress can be 
made among EMS system responders to reduce 
their risk. According to recent news broadcast 
(KVOA, Tucson, Arizona), Tucson Arizona Fire 
Department reported no cases of MRSA, which 
was down from 26 cases over a period of years. In 
2007, the department worked with Mel and Enid 
College of Public Health to develop training 
to prevent contamination. They implemented 
changes such as using hand sanitizers and special 
cleaners, replacing fabric-cove red furniture with 
cleanable fabric, and confining turnouts to the 
work area. 

Tuberculosis risk assessment 

EMS agencies are advised to go to the CDC 
website to determine the tuberculosis (TB) risk 
for the particular area and to implement a TB 
elimination program. The following sites provide 
information to develop a TB Exposure Prevention 
and Skin Testing Policy: 

http: / / www.cdc.gov/ tb / 

http: / / www.cdc.gov/ tb/publications/gui delines/ 
Control_Elim.htm 

Needlestick safety and 
prevention act 

In response to continued problems with accidental 
sharps injuries, Congress passed modifications to 
the OSHA Bloodborne Pathogens Standard which 
went into effect in 2001. EMS agencies can access 
an easy-to-use frequently asked question guide on 
this topic at: http://www.osha.gov/needlesticks/ 
needlefaq.html 


26 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


A Needlestick-Prevention Device evaluation form 
can be found at: http://www.osha.gov/OshDoc/ 
Directive_pdf/CPL_2-2_69_APPBForm2.pdf 


Resources 

Sexton J, Reynolds KA, Peate W. Study of MRSA 
bacteria in the fire station environment. Executive 
Summary, April 9, 2008. 


Association for Professionals in Infection Control and Epidemiology 27 



Guide to Infection Prevention in Emergency Medical Services 


Section 4: Surveillance 


Historically, EMS agencies have not conducted 
active surveillance programs. Currently there are 
no national benchmarks for EMS to compare 
infectious diseases, hazmat exposures, and sharps 
injuries. Each EMS agency must ensure they have 
a strong internal method of defining diagnosed 
cases or incidences and time period for each type 
of infectious disease, hazmat exposure, and sharps 
injuries that EMS system responders report. 

This section presents basic surveillance 
methodology and an example of surveillance 
in EMS. For more in-depth information on 
surveillance, refer to chapter 3, Surveillance, in 
APIC Text of Infection Control and Epidemiology, 
3rd edition (also available online at http://text. 
apic.org; subscription required to access). 

Purpose 

Surveillance is an essential element of any 
infection prevention program. 1 The purpose 
of surveillance is to identify trends, outbreaks, 
emerging infectious diseases, MDROs, sharps 
injuries, and bioterrorism events so infection 
prevention measures can be implemented. 

Key concepts 

• Surveillance methods continue to evolve 
as healthcare delivery systems shift out of 
traditional hospital facilities. 

• A surveillance program should be designed 
in accordance with current practices and 
should consist of defined elements. 

• Surveillance activities should include 
identifying risk factors for infection and 
other adverse events, implement risk- 
reduction activities, and monitor the 
effectiveness of interventions. 


• Surveillance programs in EMS should 
include infection prevention, performance 
improvement, patient safety, and public 
health activities. 

Mandatory state and federal reporting 
requirements frame surveillance programs. 

Components of infection 
prevention surveillance plan 

• Select the surveillance methodology. 

• Assess and define the population (s) to be 
studied. 

• Choose the indicators (events) to monitor. 

• Determine time period for observation. 

• Identify surveillance criteria. 

• Identify date elements to be collected. 

• Determine methods for data collection 
and management. 

• Determine methods for data analysis. 

• Identify recipients of the surveillance 
report. 

• Develop a written surveillance plan. 

Example of surveillance in EMS: 
Pertussis (Whooping Cough) - 
re-emergence of a disease in 
Oregon 

In 2010, surveillance in Oregon led public health 
authorities to launch Metropolitan Area Pertussis 
Surveillance (MAPS), enhancing surveillance 
in certain counties to better delineate the 
epidemiology of pertussis. Each reported case was 
investigated extensively and standardized data was 
collected. 


28 Association for Professionals in Infection Control and Epidemiology 




Guide to Infection Prevention in Emergency Medical Services 


Surveillance methodology 

Healthcare systems use one of three surveillance 
methodologies: total or whole house, targeted, or 
a combination of targeted and whole house. CDC 
surveillance requirements have moved increasingly 
to targeted surveillance that focuses on specific 
patient populations and/or specific infections, 
procedures, or epidemiologically significant 
organisms (e.g., MRSA). 

In this example, targeted surveillance methodology 
focused on EMS system responders who were 
at increased risk of being exposed to pertussis. 
Targeted surveillance is defined and developed 
from the risk assessment. 

Population to be studied 

Targeted surveillance may focus on persons 
at greatest risk of adverse outcome should 
they become infected. In the case of pertussis 
surveillance in Oregon, the risk assessment 
determined the population to be EMS system 
responders who were at risk for contracting 
pertussis infections due to exposure from 
the infants and children for whom they were 
providing emergency care. There was increased 
risk of transmitting the disease to other 
susceptible persons, including unimmunized or 
incompletely immunized infants and children, 
including their own. 

Indicator monitors and time period 

Indicators are based on population served, 
procedures performed, and services provided. The 
indicator may be all EMS system responders in the 
workforce with a pertussis infection diagnosis. 

The time period of surveillance activities is based 
on the needs of the organization and the scope of 
activities, but it must be long enough to accrue a 
sufficient number of cases for valid analysis. The 
time period may be a few months to a year. 

In this case study, incidence and prevalence 
(below) were monitored annually. 


Surveillance criteria 

These must be clear, concise, and consistent so it 
will be comparable to historical data. 

Data elements 

Data elements should be determined based on 
the type of infection, event, or organism being 
monitored and the statistical elements that will be 
used to analyze the data. Data elements were useful 
in characterizing pertussis cases. Typical elements 
used are age, gender, diagnosis date, source patient 
information, culture date, culture source, and 
presence of known pertussis risk factors. 

incidence and prevalence 

Incidence rates measure the probability that 
healthy people will develop a disease or sustain an 
injury during a specified period of time. It is the 
number of new cases in a population over a period 
of time (usually one year). Incidence tells us the 
rate at which new disease or injury occurs in a 
defined group of people with no previous record 
of that disease or injury. 

Incidence rate = 

Number of new cases over a period of time 
Population at risk 

Prevalence rates measure the number of people in 
a population who have the disease or injury at a 
given time. Prevalence depends on the number of 
people who have been ill in the past and duration 
of the illness. A prevalence rate will include all 
new incidence of the disease at the time it is 
measured. Therefore prevalence includes both new 
and existing cases. 

Prevalence rate = 

Number of existing cases at a point in time 
Total population 

When using incidence rates, the population at 
risk is that subset of the total population that 
is specifically at risk for developing a disease or 
sustaining an injury. 


Association for Professionals in Infection Control and Epidemiology 29 



Guide to Infection Prevention in Emergency Medical Services 


In the pertussis example, the surveillance data 
revealed that cases of pertussis in Oregon had 
tripled in number from the same time the 
previous year. In the fall of 2011 when the 
Portland fire and rescue department first began 
to see the number of pertussis cases rise in 
nearby Washington state and in Oregon, the 
department proactively offered all firefighters 
the tetanus, diphtheria, and acellular pertussis 
(Tdap) vaccination. Because cases of pertussis 
occur in adults because of decline in protective 
immunity over time, the Tdap vaccine would 
not only protect the firefighters themselves, but 
it would also help protect their families and 
high-risk children and infants to which they 
provide care. Although there was an increase 
in the number of pertussis cases in the general 
population, no firefighters have reported 
contracting pertussis since the Tdap vaccine was 
offered. 

CDC now requires all EMS system providers 
who have not previously received the Tdap 
vaccine as an adult, and who have direct patient 
contact, to receive a single dose of Tdap to 
protect EMS system providers and their patients 
against pertussis. Tdap can be administered 
regardless of interval since the previous tetanus- 
diphtheria (Td) dose; however, shorter intervals 
between Tdap and Td may increase the risk 
of mild local reaction at injection site. 2 EMS 
agencies can purchase Tdap vaccine through 
their local health departments. For more 
information related to this requirement, Tdap 
consent and declination forms go to: http:// 
www.cdc.gov/vaccines/who/teens/vaccines/tdap. 
html 

Surveillance data analysis and 
management 

Before initiating data collection, it is important to 
determine the statistical measures that will be used 
in data analysis. If rates or ratios will be calculated, 
the values corresponding to each numerator and 
denominator must be defined. 


At this time, EMS surveillance is not as 
sophisticated as hospital-based surveillance. EMS 
systems across the United States may track the 
number of cases of EMS responders diagnosed 
with pertussis; however, there is no comparison 
of data across agencies. An agency could track 
and report pertussis incidents and rates using a 
standardized definition, such as: 

New pertussis case = pertussis-positive 
diagnosis from EMS responder with new 
onset history of pertussis divided by the 
number of EMS responders in the study 
population in a particular time period. 

Written surveillance plan 

A written surveillance plan should describe the 
objectives, the indicators (monitors), the reason 
for selecting each indicator, the methodology used 
for case identification, data collection, analysis, 
and the type of reports generated. The surveillance 
plan should be developed to address the specifics 
of the organization. 

Surveillance program evaluation 

The surveillance program should be evaluated 
at least annually to determine trends and the 
efficacy of actions, as well as its usefulness and 
ability to meet the organizations objectives. 
Revisions should be made at time of review, or 
sooner when indicated by ongoing surveillance 
results if changes in incidence or outbreaks are 
identified. If an outbreak occurs or incidences of 
a certain disease increases, action should be taken 
immediately to meet the organizations stated 
objectives. 

Cited References 

1 Carrico R, ed. APIC text of infection control and 
epidemiology. Washington, DC: Association for 
Professionals in Infection Control and Epidemiology, 
Inc., 2009. 


30 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


2 Immunization of health-care workers: 
recommendations of the Advisory Committee for 
Immunization Practices (ACIP) and the Hospital 
Infection Control Practices Advisory Committee 
(HICPAC). MMWR Recomm Rep Dec 26 
1997;46(RR-18):l-42. 


Additional Resources 

Carrico R, ed. APIC text of infection control and 
epidemiology. Washington, DC: Association for 
Professionals in Infection Control and Epidemiology, 
Inc., 2009; chapter 3. 


Association for Professionals in Infection Control and Epidemiology 31 




Guide to Infection Prevention in Emergency Medical Services 


Section 5: Engineering and Work Practice 
Controls and Personal Protective Equipment 


Purpose 

Engineering and work practice controls and PPE 
are key components to a comprehensive infection 
prevention program. They maximize protection 
against infectious diseases and sharps-related 
injuries for both EMS system responders and the 
public. The term engineering controls addresses 
redesign of equipment to ensure employee 
risk reduction, procedures that serve to reduce 
exposure such as cleaning equipment or areas that 
have been contaminated, and the use of barrier 
techniques to reduce direct contact with blood 
and other potentially infectious materials. 

Key concepts 

• Hand washing is the single most 
important means of preventing the spread 
of disease (see example of proper hand 
hygiene at the end of this section). 

• Risk of exposure to infectious diseases 
and sharps-related injuries can be greatly 
reduced and eliminated by introducing 
and adhering to best practices and the 
Needlestick Safety and Prevention Act 
of 2000 for engineering and workplace 
controls. 

• The word “personal” in PPE means EMS 
system responders are responsible to 
wear PPE for their own personal safety. 
Supervisors and DICOs are responsible 
to ensure their employees are adhering to 
policies. 

• The use of Standard Precautions and 
utilizing PPE for all patient contact is 


recommended to minimize infectious 
disease transmission to EMS system 
responders. 

• Any body fluid containing visible blood 
and other potentially infectious materials 
(OPIM) pose increased risk. OPIM 
include the following: 

° Cerebrospinal fluid 
° Synovial fluid 
° Amniotic fluid 
° Pericardial fluid 
° Vaginal secretions 
° Semen 

• Effective environmental cleaning, 
disinfection, and disposal of contaminated 
materials or equipment will reduce the 
risk of infectious disease transmission. 

Background 

The U.S. Department of Labor estimates there 
are approximately 1.5 million EMS personnel and 
firefighters (many of whom are crossed trained in 
EMS) and 794,300 police and detectives along 
with 493,100 correctional officers who are at 
risk for being exposed to infectious diseases and 
sharps-related injuries. 1 EMS system responders 
and their patients face a growing number of 
exposures to infectious diseases including 
MDROs. Self-protection from infection includes 
cleaning and disinfecting ambulances, fire 
apparatus, patrol cars, and equipment. In order 
to prevent infectious disease exposures there 
must be an emphasis placed on the commitment 


32 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


to establishing an organizational culture that 
encourages the proper use of PPE and adherence 
to policies and procedures. This chapter details 
methods EMS system responders can utilize to 
maintain a clean, safe work environment. 

Standard Precautions 

Standard Precautions are based on the principle 
that all blood, body fluid secretions, excretions 
(except sweat), nonintact skin, and mucous 
membranes may contain infectious organisms. 
Implementation of Standard Precautions is the 
primary strategy preventing healthcare-associated 
transmission of infectious agents among patients 
and healthcare personnel. 2 Standard Precautions 
are intended to be applied to the care of all 
patients in EMS and healthcare settings. These 
practices include: hand hygiene, use of PPE 
(gloves, gown, mask, eye protection or face shield, 
depending on the anticipated exposure), and safe 
injection practices. See Table 2.4 in Section 2 for 
an overview of Standard Precautions components. 

PPE can prevent blood and other body fluids 
from coming in contact with skin, eyes, and 
mouth. 3 Equipment or items in the patient 
environment likely to have been contaminated 
with infectious body fluids must be handled in 
a way that prevents transmission of infectious 
agents (e.g., wear gloves for handling soiled 
equipment, properly clean and disinfect or sterilize 
reusable equipment before use on another patient, 
ensure the appropriate disposal of contaminated 
disposable items). 

The application of Standard Precautions during 
patient care is determined by the nature of the 
emergency responder-patient interaction and 
the extent of anticipated blood, body fluid, or 
pathogen exposure. For some patient care, such as 
starting an IV, only gloves may be needed. When 
a patient is being intubated the use of gloves and 
face shield or mask and goggles are required. 
OSHA requires a chart that lists tasks and PPE to 
be used when performing tasks (see page 51). 


Another mode of disease transmission is 
respiratory (e.g., cough, congestion, or droplets 
from the nose). Respiratory/cough etiquette 
recommendations are intended to decrease the 
spread of infectious particles that are expelled 
via respiratory droplets. There are four primary 
components: education, source control, hand 
hygiene, and spatial separation. 

EMS system responders are advised to wear a 
mask, gloves, and eye protection when examining 
and caring for patients with signs and symptoms 
of a respiratory infection, fever, or flu-like 
symptoms (temperature range 100°F or greater, 
runny nose, cough, sneezing, and bodily aches). 
They must take precautions by covering the 
mouth and nose of a potentially infectious patient 
with a tissue when the patient is coughing, 
properly disposing of used tissues, using a surgical 
mask on the coughing patient when tolerated 
and appropriate, and washing their hands after 
contact with respiratory secretions or droplets. 

To minimize the risk of respiratory transmitted 
infection, it is advisable to keep a safe distance 
(if possible, at least 6 feet) from the patient. 4 
Minimize the number of crew members caring 
for the patient and within the breathing/coughing 
zone of the patient. 

The CDC’s Public Health Guidance for 
Community Level Preparedness and Response 
to Severe Acute Respiratory Syndrome (SARS) 5 
recommends the receiving facility staff meet 
the patient at the ambulance door to limit the 
need for EMS system responders to enter the 
emergency department in contaminated PPE. 
After transferring the patient, the EMS system 
responder should remove and discard their PPE 
and perform hand hygiene. This can be done 
for other types of infectious diseases other than 
SARS. These simple measures are very important 
during an infectious disease disaster. A 2004 study 
found that 40 percent of healthcare personnel 
who developed SARS after exposures to coughing 
patients had not been wearing a mask or eye 
protection when exposed. Many, if not all of these 


Association for Professionals in Infection Control and Epidemiology 33 



Guide to Infection Prevention in Emergency Medical Services 


infections may have been prevented if healthcare 
personnel had been wearing respiratory and eye 
protection. 

Hand hygiene is also an important component of 
respiratory etiquette and critical response to an 
infectious disease disaster. Education about hand 
hygiene should improve knowledge and reinforce 
positive behavior. 6 

Defining engineering and work 
practice controls 

Engineering controls are devices or changes in 
the physical environment that reduce the risk of 
exposure. These are important to isolate or remove 
the infectious disease hazards from the workplace. 
Examples of these are self-sheathing IV catheters, 
needleless systems, puncture-proof containers, 
decontamination areas, masks, respirators, and 
adequate ventilation systems. 

EMS agencies need to conduct periodic surveys 
to evaluate the use of engineering controls and 
identify current needs. The process should include 
the ability to conduct appropriate evaluations 
and/or field tests to ensure the devices will not 
adversely impact the delivery of patient care or 
result in providers delaying treatment attempting 
to circumvent the intended functioning of the 
safety device. Determine whether there should 
be adjustments to the systems protocols, clinical 
operating guidelines, and educational requirements 
to integrate use of devices into the patient care 
system. 

Work practice controls are behavior-based and 
are intended to reduce the risk of exposure 
by changing the way in which the tasks are 
performed. Examples of these are avoiding passing 
a syringe with an unsheathed needle and placing 
sharps directly into appropriate sharps containers 
located as closely to the point of care as possible. 
EMS system responders have been reported to 
stick a needle in their boot, stretcher mattress, 
bench seat, and box of gloves because they stated 


they did not have a chance to grab a sharps 
container. These methods are not acceptable 
and pose increased risk of needlesticks to the 
individual, his or her colleagues, and the patient. 

Basic engineering control 
components 

The following engineering controls should be in 
use at each station or apparatus: 

• Hand washing facilities 

• Availability of alcohol-based hand 
cleansers or towelettes for on-scene use 

• Disinfectant wipes for equipment 

• Self-sheathing IV catheters and needleless 
systems 

• Puncture-resistant, leak-proof, color- 
coded, conveniently located sharps 
containers that are available on response 
apparatus 

• Leak-proof, properly labeled, and 
conveniently located contaminated-waste 
receptacles 

• Decontamination areas at stations (see 
page 34 for description) 

• Single-use devices in place of reusable 
devices 

The Federal Needlestick Safety and Prevention 
Act provides additional guidance on sharps injury 
prevention. 7 

All EMS system responders that have rotating or 
changing assignments should be oriented to the 
engineering controls in the station or apparatus by 
a designated and knowledgeable person. 

Basic work practice controls 

The following work practice controls must be used 
by all personnel: 

• Wash hands or use antiseptic hand 
cleaner 8 before and after patient care, 


34 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


before and as soon as gloves are removed, 
on returning to the station, after cleaning 
or decontaminating equipment, after 
using the restroom, and before preparing 
food. 

• Flush eyes or mucous membranes with 
large amounts of water or saline if exposed 
to blood or body fluids. 

• Dispose of sharps in puncture-resistant 
containers and keep in a secure position. 

• Do not eat, drink, smoke, or handle 
contact lenses or apply lip balm in areas 
of possible contamination (in emergency 
vehicles, on scene, or while cleaning 
equipment). 

• Use pocket masks or bag valve masks for 
ventilation. 

• Do not keep food and drink in 
refrigerators designated biohazard 
with potentially infectious materials or 
medications. 

• Place blood specimens in marked plastic 
bags for transport. 

• Dispose of sharps containers when three- 
quarters full or when at the full line. 

• Appropriate identification and disposition 
of medical waste according to state 
regulations. 

Personal protective equipment 

PPE is barrier protection and the last line of 
defense to prevent occupational exposure to 
blood or body fluids. PPE is necessary because 
all exposures cannot be minimized or eliminated 
by engineering or work practice controls. PPE 
reduces the risk but is only effective if used cor¬ 
rectly. The use of PPE does not replace basic 
hygiene measures. Hand washing is still essential 
to prevent transmission of infection. 

Appropriate use of gloves helps protect both EMS 
system responders and patients from exposures to 
infectious diseases. Nonsterile disposable medical 
gloves should be available to all EMS system 


responders. Gloves manufactured for healthcare 
purposes are subject to U.S. Food and Drug 
Administration (FDA) evaluation and clearance. 9 
Gloves are available in vinyl, nitrile, and latex. If 
possible, avoid use of latex and nitrile gloves due 
to latex sensitivity in personnel and patients and 
documented problems with nitrile gloves. Due to 
the sometimes dangerous conditions under which 
EMS system responders have to provide patient 
care (i.e., motor vehicle accidents), it is highly 
recommended to use an alternative, more durable 
type glove and/or use a double gloving routine. 

If fire-fighting gloves are worn over medical 
gloves, wash them with disinfectant detergent 
upon returning to the station or according to 
manufacturers instructions. 

Masks can protect EMS system responders from 
infectious diseases, respiratory exposures, and 
splashes of blood and other body fluids. States 
vary on their mask requirements. Check state 
rules. Departments required to use masks should 
provide personnel with well-fitting surgical/ 
medical or N95 respirators. If employers choose 
the NIOSH-approved N95 respirator they are 
required by OSHA to conduct an initial medical 
clearance, provide fit testing (respirator fit testing 
performed to determine if an employee can 
maintain an acceptable respiratory fit and seal), 
education on proper use, and conduct periodic 
(annual at a minimum) re-evaluation. 10 

Goggles or safety glasses for eye protection should 
be issued. They should fit comfortably and 
securely and allow for peripheral vision. EMS 
system responders can also use prescription glasses 
with removable side shields per OSHA. These 
protect from splashes and respiratory diseases 
spread by droplets. 

When exposure to large amounts of blood or body 
fluid is anticipated, the use of a gown, sleeves, or 
booties over boots is also recommended. 

The employer is responsible for the supply, repair, 
replacement, and safe disposal of contaminated 
PPE. EMS system responders must report any 


Association for Professionals in Infection Control and Epidemiology 35 



Guide to Infection Prevention in Emergency Medical Services 


issues with PPE verbally and in writing to their 
manager. Reusable PPE should be cleaned after 
every use or as needed. The following guidelines 
should be followed when using PPE: 

• Discard all disposable contaminated 
PPE in appropriate containers as soon 
as feasible. Follow your state rules for 
discarding contaminated PPE. 

• Remove and appropriately dispose of 
gloves when they become soiled or torn. 

EMS system responders, including police and 
correctional officers, should carry an extra change 
of work clothing with them at all times in the 
event their work clothes are grossly contaminated 
in the course of their work. 

Although there are no known documented 
transmissions of HBV or HIV during mouth-to- 
mouth resuscitation, due to the risk of salivary 
transmission of other infectious diseases (e.g., 
herpes simplex, Neisseria meningitidis ), disposable 
airway equipment or resuscitation bags should 
be used during artificial ventilation. Disposable 
equipment is preferred but if multiuse equipment is 
used, follow the manufacturers recommendations 
for cleaning and disinfection. 

Law enforcement and 
correctional facility officers 

Officers may face the risk of exposures to blood 
during the conduct of their duties. They may 
encounter blood-contaminated hypodermic 
needles or weapons or be called upon to assist 
with body removal. In order to reduce risk, the 
following guidelines should be followed 11 : 

• When blood is present and a suspect or 
inmate is combative or threatening to 
staff, gloves should be put on as soon as 
conditions permit. 

• Protective masks or airways should be 
easily accessible in case mouth-to-mouth 
is needed. 


• Due to the risk of puncture wounds or 
needlesticks during suspect searches, an 
officer should use extreme caution in 
searching the clothing of suspects. Wear 
protective gloves, especially for body 
searches. 

• Always use a flashlight to search such 
areas as under the seat of a car or purse to 
avoid being stuck. 

• To avoid tearing gloves, use evidence tape 
instead of staples to seal evidence. 

• Use puncture-proof containers to store 
sharp instruments. 

• Use thick gloves to search suspects. 

• Avoid handling personal items while 
wearing contaminated gloves. 

• Prisoners may spit at officers and throw 
feces; sometimes these substances have 
been purposefully contaminated with 
blood. Although there are no documented 
cases of HBV or HIV transmission from 
this, other diseases could be transmitted. 
These materials should be removed after 
donning gloves then decontaminate with 
an appropriate germicide and dispose of 
gloves properly. 

Environmental 

decontamination 

General principles of disinfection 

The rationale for cleaning, disinfecting, or 
sterilizing patient care equipment can be 
understood more readily if medical devices, 
equipment, and surgical materials are divided 
into three general categories based on the 
potential risk of infection involved in their use: 
critical items, semicritical items, and noncritical 
items. 

Critical items are instruments such as needles or 
surgical instruments that are introduced directly 
into the bloodstream or into other normally sterile 
areas of the body. These items are sterile at the 
time of use. 


36 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Semicritical items are items such as laryngoscope 
blades, Magill forceps, and other items that may 
come in contact with mucous membranes but do 
not ordinarily penetrate body surfaces. Although 
sterilization is preferred for these instruments, a 
high-level disinfecting procedure that destroys 
microorganisms, most fungal spores, tubercle 
bacilli, and small nonlipid viruses may be used 
after meticulous physical cleaning to remove any 
visible contamination. 

Noncritical items either do not ordinarily touch 
the patient or touch only intact skin. 

Items include splints, backboards, and blood 
pressure cuffs. Disinfect noncritical items by 
cleaning with soap and water followed by 
disinfection with an appropriate disinfectant. 
Equipment must be thoroughly cleaned with soap 
and water and scrubbed to remove organic matter 
(blood and tissue) and other residue. Cleaning 
must precede disinfection because organic matter 
shields organisms from destruction and may 
inactivate some disinfectants. Scrubbing to remove 
gross decontamination is more effective than 
soaking because soaking does not always remove 
all contaminants. 

Disinfection procedures 

General procedure 

Upon the completion of all responses, 
contaminated equipment should be removed and 
replaced with clean equipment. Supplies of PPE 
on response vehicles should also be restocked. 
Contaminated equipment should be placed 
in a leak-proof bag and segregated from clean 
equipment. Cleaning and decontamination should 
be done as soon as practical. 

Utility gloves should be worn when cleaning 
equipment and when using disinfectants to 
protect the skin from damage and contamination. 
OSHA states that the employer should base the 
selection of appropriate hand protection on an 
evaluation of the performance characteristics of 


the hand protection relative to the task(s) to be 
performed, conditions present, duration of use, 
and the hazards and potential hazards identified . 9 

Wash hands and change clothes, if necessary, 
after decontamination of equipment and 
clothing. Before disinfection, equipment must 
be thoroughly cleaned with soap and water and 
scrubbed to remove organic matter (blood and 
tissue) and other residue. 

Ensure cleaned items are properly stored to prevent 
reinfection or contamination during storage. 

Disinfection solutions 

Select U.S. Environmental Protection Agency (EPA)- 
registered disinfectants or detergent/disinfectants 
that meet the departments routine cleaning and 
disinfection guidelines . 12 Follow manufacturers 
guidelines for appropriate selection and use of 
disinfecting solutions, and pay special attention to 
the prescribed contact time. 

Decontamination stations 

Each station is required by OSHA to have a 
decontamination area. These areas should be 
marked with decontamination area and biohazard 
signs and symbols and equipped with the 
following: 

• A sink, constructed of nonporous 
materials with proper lighting 

• Adequate counter areas constructed of 
nonporous materials with rack space to 
allow air-drying of equipment 

• Appropriate containers for disposal of 
biohazard waste (receptacles/red bags) 

• Facilities for the safe storage, use, and 
disposal of cleansing and disinfecting 
solutions along with appropriate PPE 
(safety glasses/goggles, utility gloves, face 
masks) 

• Material safety data sheets (MSDSs) 
for cleaning and disinfecting solutions. 
MSDS information may be kept 


Association for Professionals in Infection Control and Epidemiology 37 



Guide to Infection Prevention in Emergency Medical Services 


electronically; however, they must be 
accessible to all employees and updated as 
new products are purchased 

• Liquid soap and paper towels 

• Sharps container 

All EMS system responders using these solutions 
should be familiar with the MSDS and should use 
the recommended PPE. Under no circumstances 
should kitchens, bathrooms, or living areas be 
used for decontamination or storage of patient 
care equipment or infectious waste. 

Equipment decontamination 

1. Semicritical items such as laryngoscopes, 
Magill forceps, and bag mask ventilation 
devices: Clean and scrub with soap and water, 
paying attention to crevices. Soak in disinfectant 
per manufacturer’s instructions. Thoroughly rinse 
equipment several times with copious amounts 
of water. Each rinse should be a minimum of 1 
minute in duration unless otherwise noted by the 
device or equipment manufacturer. 

2. Delicate equipment such as cardiac monitors, 
defibrillators, glucometers, and radios: Clean 
with soap and warm water and wipe or spray with 
disinfectant. Do not spray disinfectant on the 
screen or controls of the monitors or defibrillators. 
Use disinfectants or ready-to-use disinfectant wipes 
on paddles and wires. 

3. Patient transport equipment such as 
backboards, extrication devices, etc.: Clean and 
scrub with soap and warm water, paying attention 
to crevices, and wipe or spray with appropriate 
disinfectant and allow equipment to air-dry. 

4. Medical/Trauma/Pediatric Kits: Empty 
contents weekly and wash kit with soap and water. 
Wipe or spray with disinfectant, and let air-dry. 

5. Emergency Apparatus (engines, trucks, 
rescues, patrol vehicles): Exterior and interior 
surfaces of vehicles, especially those areas 


that are commonly handled by EMS system 
responders (e.g., door handles, steering wheel, 
clipboard, etc.), should be disinfected at least 
weekly and after each call where the potential for 
contamination exists. Wipe with soap and water 
then wipe or spray with disinfectant and allow a 1 
minute contact time (air-dry). 13 

6. Miscellaneous equipment such as 
stethoscopes, thermometers, blood pressure cuffs, 
instrument cases, sharps containers: These items 
should be disinfected weekly and after each call 
where potential for contamination exists. Wipe 
with soap and water and then wipe or spray with 
disinfectant and let air-dry. When contamination 
of shoes worn on calls is suspected, shoes should 
be cleaned with soap and water before entering 
living quarters. 

7. Stations/Living quarters: Recent research 
shows increased rates of MRSA in fire stations, 
ambulances, and fire apparatuses. 14 Crews must 
clean or disinfect their equipment and items 
inside their stations to include counters, door 
handles, remote controls, sinks, furniture, 
exercise equipment, and any other shared use 
items. An appropriate disinfectant or a 1:100 (1 
part bleach to 99 parts of water) concentration 
of water to household bleach can be used to 
clean most surfaces. The bleach solution should 
always be made just prior to its use to ensure 
effectiveness. 15 

8 . Soiled or contaminated uniforms, bunker 
gear, turnouts: Wash immediately with detergent. 
Contaminated bunker gear/turnouts should 

be cleaned according to the manufacturer’s 
recommendation and National Fire Protection 
Association (NFPA) 1581. 

9. Boots and shoes: When there is a massive 
amount of blood contamination on floors, the use 
of disposable impervious shoe coverings should 
be considered. Boots and leather goods may be 
brush scrubbed with soap and water to remove 
contamination. 


38 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


10. Oxygen tanks: Spent oxygen tanks should be 
visibly inspected and cleaned/disinfected if they 
are contaminated with blood or OPIM. 

Blood and body fluid spills 

Use layered disposable superabsorbent pads on 
large amounts of blood. Wearing proper PPE, 
place the needed number of pads over the liquid. 
Liquid will be absorbed quickly into the pad for 
safer handling. Carefully pick up the pad and 
place in red biohazard bag. Use disinfectant and 
apply over the affected area and, if needed, rinse 
the affected area with a small amount of water. 

Skin and mucous membranes 

Any intact skin contamination to blood or body 
fluids should be removed by washing with soap 
and water. Vigorously wash the affected area for 
a minimum of 15 seconds. Examine exposed 
skin for any breaks or rough chapped areas. 

Any nonintact skin should be covered with a 
dressing directed by OSHA. If the area is too 
large, personnel should be placed on restricted 
duty until their wound heals. Do not use strong 
chemical solutions like bleach or an approved 
disinfectant solution to disinfect skin as they 
can cause skin irritation and allergic problems. 
Any mucous membrane exposure to blood or 
body fluids should be decontaminated by rinsing 
with large amounts of water or saline solution. 
Rinse the affected area for 2 minutes. Eyes may 
be irrigated using large amounts of water. Rinse 
the affected eye(s) for 3 minutes. If this is not 
available, saline solution and IV tubing may be 
used. 

Disposal of contaminated items 

Disposable equipment and other waste generated 
during on-scene operations should be discarded 
into an appropriate waste container. Used 
needles and other sharps should be disposed of 
in approved sharps containers. Sharps containers 
should be easily accessible on scene. Blood, 
suctioned fluids, or other liquid waste may be 
poured carefully into a drain connected to a 


sanitary sewer system. Self-contained suction 
canisters should be recapped and placed in a 
sealable plastic bag to prevent leakage of the 
contained items. 

Ambulance and rescues 

These vehicles are mobile patient care 
environments. Air circulation in the vehicle 
is generally rapid, low-velocity airflow. Some 
ventilation systems fully exchange patient care air 
space in 1 to 2 minutes. Some vehicles have high- 
efficiency particulate air (HEPA) filters which 
need to be changed every 6 months. There are 
also exhaust fans to assist in air exchange. These 
air handling systems allow for good ventilation. 
However, if a patient is exhibiting the signs of a 
respiratory disease such as presented earlier in the 
guide, place a mask or tissue over their mouth as 
tolerated. 

The ambulance cab should be maintained as a 
“clean zone,” free of contamination. Gloves or other 
PPE used during patient care should be removed 
prior to entering the cab. Grossly contaminated 
clothing should also be removed before entering the 
cab and place the clothes in an appropriate dirty or 
contaminated linen bag as marked. 

The ambulance cab should be promptly 
decontaminated with detergent or disinfectant 
at the earliest practical opportunity following 
contamination. 

A detailed ambulance cleaning procedure can be 
found in Appendix A. 

Emerging technologies 

With the increase in community-associated 
infections and threats of contamination of 
EMS system responders, systems continue to be 
developed to disinfect EMS vehicles. 

Recently approved by CDC for hospital room 
disinfection, “fogging” systems previously tested 
and used in stationary medical units such as 
hospitals may hold promise for disinfecting EMS 


Association for Professionals in Infection Control and Epidemiology 39 



Guide to Infection Prevention in Emergency Medical Services 


vehicles. Research on the use of this technology Additional technologies, chemicals, and systems 

in EMS needs to be performed. Most of these continue to be explored and tested in order 

systems utilize an alcohol-based chemical that to improve vehicle decontamination. It is 

is able to penetrate ventilation ducts, under mandatory that whenever any cleaning product is 

equipment, and in various cracks and crevices added to a departments chemical inventory, even 

often missed during routine manual sanitizing. products under trial use, that the MSDS is added 

How to Handwash? 

WASH HANDS WHEN VISIBLY SOILED! OTHERWISE, USE HANDRUB 



Wet hands with water; Apply enough soap to cover Rub hands palm to palm; 

all hand surfaces; 



Right palm over left dorsum with Palm to palm with fingers Interlaced; Backs of fingers to opposing palms 

Interlaced fingers and vice versa; with fingers Interlocked; 



Rotational rubbing of left thumb Rotational rubbing, backwards and Rinse hands with water; 

clasped in right palm and vice versa; forwards with clasped Ungers of right 

hand In left palm and vice versa; 



Dry hands thoroughly Use towel to turn off faucet; Your hands are now safe, 

with a single use towel; 



Source: http://www.cdc.gov/handhygiene/Basics.html 


40 Association for Professionals in Infection Control and Epidemiology 








Guide to Infection Prevention in Emergency Medical Services 


to the department’s electronic MSDS inventory 
and printed for inclusion in the paper MSDS 
inventory. All secondary containers (spray/ 
squirt bottles) for the dispensing of disinfection 
solutions need to be labeled with the appropriate 
contents. 

Cited References 

1 Bureau of Labor Statistics, U.S. Department of 
Labor. Occupational outlook handbook, 2008-09 edition, 
emergency medical technicians and paramedics. Available 
at: http://www.bls.gov/ooh/Healthcare/EMTs-and- 
paramedics.htm. Accessed December 13, 2012. 

2 Siegel JD, Rhinehart E, Jackson M, Chiarello L, 

The Healthcare Infection Control Practices Advisory 
Committee. The guideline for isolation precautions: 
preventing transmission of infectious agents in healthcare 
settings 2007. Available at: http://www.cdc.gov/hicp 
ac/2007ip/2007isolationprecautions.html. Accessed 
December 13, 2012. 

4 OSHA. Bloodborne pathogen standard (29CFR 
Part 1910.1030). Washington, DC: Department 
of Labor, Occupational Safety and Health 
Administration. Available at: http://www.osha. 
gov/pis/oshaweb/owadisp.show_document?p_ 
table=standards&p_id= 10051. Accessed December 
13, 2012. 

5 OSHA. Guidance on preparing workplaces for an 
influenza pandemic. Available at: http://www.osha. 
gov/Publications/OSHA3327pandemic.pdf. Accessed 
December 13, 2012. 

6 CDC. Public health guidance for community-level 
preparedness and response to severe acute respiratory 
syndrome (SARS). Available at: http://www.cdc.gov/ 
sars/guidance/I-infection/prehospital.html. Accessed 
December 13, 2012. 

7 McGuire-Wolfe A, Haiduven D, Hitchcock CD. A 
multifaceted pilot program to promote hand hygiene 
at a suburban fire department. Am J Infect Control 
2012;40:323-327. 

8 OSHA. Needlestick Standard Precautions. Available 
at: http://www.osha.gov/SLTC/bloodbornepathogens/ 
standards.html. Accessed December 13, 2012. 


9 CDC. Guidelines for hand hygiene in healthcare 
settings. Available at: http://cdc.gov/handhygiene/ 
Guidelines.html. Accessed December 13, 2012. 

10 OSHA. Hand protection. Available at: http:// 
www.osha.gov/Publications/osha3151 .html. Accessed 
December 13, 2012. 

11 OSHA. Respiratory protection. Available at: http:// 
www.osha.gov/SLTC/respiratoryprotection/index. 
html. Accessed December 13, 2012. 

12 CDC. Guidelines for prevention of 
transmission of human immunodeficiency virus 
and hepatitis B virus to health-care and public 
safety workers. A response to P.L. 100-607 The 
Health Omnibus Programs Extension Act of 1988. 
Available at: http://www.cdc.gov/mmwr/preview/ 
mmwrhtml/0000l450.htm. Accessed December 13, 
2012. 

13 Rutala WA, Weber DJ. Disinfection and 
sterilization in health care facilities; what clinicians 
need to know. Clin Infect Dis 2004;39(5):702-709. 

14 Rutala WA, Weber DJ and the Healthcare Infection 
Control Practices Advisory Committee. Guidelines 

for disinfection and sterilization in healthcare facilities 

2008. Available at: http://www.cdc.gov/hicpac/ 
Disinfection_Sterilization/3_4surfaceDisinfection. 
html. Accessed December 13, 2012. 

15 Roberts MC, Soge OO, No D, Beck NK, Meschke, 
JS. Isolation and characterizations of methicillin- 
resistant Staphylococcus aureus (MRSA) from fire 
stations in two northwest fire districts. Am J Infect 
Control 2011;39:382-389. 

16 Martin A, Dworsky PI. On the road with pre¬ 
hospital infection control, infection control technologies, 

2009. Available at: http://www.infectioncontroltoday. 
com / articles/2011/01/ on-the-road-with-pre-hospital- 
infection-control.aspx. Accessed December 13, 2012. 

Additional Resources 

Standard on Fire Department Infection Control 
Program. National Fire Protection Association, 

(NFPA) 1581. Available at: http://www. 
nfpa.org/AboutTheCodes/AboutTheCodes. 
asp?docnum=1581 &tab=docinfo 


Association for Professionals in Infection Control and Epidemiology 41 



Guide to Infection Prevention in Emergency Medical Services 


Needlestick Safety and Prevention Act. http://frwebgate. 
access.gpo.gov/ cgi-bin / getdoc.cgi?dbname= 106_cong_ 
public_laws&docid=f:publ430.106 


OSHA Enforcement Procedures for the Occupational 
Exposure, http://www.osha.gov/pls/oshaweb/owadisp. 
show_document?p_table=DIRECTIVES&p_id=2570 


OSHA Bloodborne Pathogen Standard. http://www. 
osha.gov/SLTC/bloodbornepathogens/gen_guidance. 
html 


42 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


Section 6: Occupational Exposure Health 
Issues 


Purpose 

Anyone whose job requires providing EMS 
system response medical care in which there is 
a reasonable expectation of contact with blood 
or OPIM is at risk for contracting an infectious 
disease. 112 Communication, collaboration, 
planning, and using PPE can prevent and/or 
mitigate, to a great extent, the outcomes of such 
exposures. This chapter identifies infection risks 
and possible solutions. 

Key concepts 

• EMS agencies need to provide a safe 
environment for their staff. 

• The DICO has a vital role in identifying 
the risks associated with the work of EMS 
system responders. 

• EMS system responders need to 
understand that exposure does not 
necessarily mean they have been 
infected. 

• An Exposure Control Plan (ECP) must 
include more than just information 

on bloodborne pathogens, and this 
information must be understood by all 
employees. 

• Management must support and 
provide the resources for appropriate 
implementation of the ECP in order for it 
to be effective. 

• Adequate and timely communication 
across healthcare settings helps address 
the unique infection transmission risks 
experienced by EMS system responders. 3 


Agencies may internally delegate infection 
issues to a DICO to focus more attention on 
infection prevention. The DICO must receive 
specialized training and be knowledgeable on 
infection prevention. This is consistent with 
the Ryan White Act and the National Fire 
Protection Standard 1581 for handling exposure 
incidents. Prior collaboration between local 
hospitals, DICOs, and those who interact with 
the potentially infected patient will enhance a 
timely response, if an employee is exposed. Some 
jurisdictions may rely solely on the Ryan White 
Act which now includes a clause that requires 
the notification of EMS system responders 
(this includes law enforcement and corrections 
officers) if a patient with which they worked is 
determined to be infectious. IPs at all medical 
facilities must be familiar with this law and 
their facility’s protocol in meeting its strict time 
requirements. Collaboration between public 
health, medical facilities, and DCIO/IPs from 
involved agencies must be ongoing. 

Bloodborne pathogen 
exposure control plan 

An understandable, functional, written ECP 
that is used daily is crucial to the success of your 
program and safety of your employees. (See 
Appendix B for a sample Exposure Control Plan.) 
All of the requirements of OSHA’s Bloodborne 
Pathogens standard can be found in Title 29 
of the Code of Federal Regulations at 29 CFR 
1910.1030. States and territories that operate their 
own OSHA-approved state programs are required 
to adopt a bloodborne pathogens standard that is 


Association for Professionals in Infection Control and Epidemiology 43 



Guide to Infection Prevention in Emergency Medical Services 


at least as effective as the federal OSHA standard. 4 
If you are implementing a new program, 
check state and federal authorities to see whose 
jurisdiction your organization must follow. 

Public employees in non-OSHA participating 
states may fall under different state regulations (or 
none). However, the plan outlined is a minimum 
standard and should be noted. 

The OSHA standard requires the following nine 
elements as the foundation of a Bloodborne 
Pathogen program (for a Quick Reference Guide 
to the Bloodborne Pathogens Standard, see http:// 
www.osha.gov/SLTC/bloodbornepathogens/ 
bloodborne_quickref.html). 

1. Determination of employee exposure 

The employer must create a list of job 


occupational exposure to blood and 
OPIM must be trained regarding 
the proper use of all engineering and 
work practice controls. 

• Personal protective equipment (PPE): 
Provide PPE such as gloves, gowns, 
eye protection, and masks. Employees 
must clean, repair, and replace this 
equipment as needed. Provision, 
maintenance, repair, and replacement 
are at no cost to the employee. 

3. Hepatitis B vaccination 

This vaccination must be offered after 
the worker has received the required 
bloodborne pathogens training and 
within 10 days of initial assignment to a 
job with occupational exposure. Written 
documentation must be kept if the 
worker declines to be vaccinated. 


classifications in which all workers have 
occupational exposure and a list of job 
classifications in which some workers 
have occupational exposure, along 
with a list of the tasks and procedures 
performed by those workers that result in 
their exposure. This list also determines 
who needs ECP training. See Example 
6.1 at the end of this section for an 
example of a job classification list for fire 
departments. 

2. Implementation, including date, of 
various methods of exposure control 
including: 

• Standard Precautions: One must 
treat all human blood and OPIM 
as if known to be infectious for 
bloodborne pathogens. 

• Engineering and work practice controls: 
Identify and use engineering controls. 
Identify and ensure the use of 

work practice controls. You should 
already have safer devices in place. 

If you have not already evaluated 
and implemented appropriate and 
available engineering controls, you 
must do so now. Also, employees with 


4. Postexposure evaluation and follow-up 

Make available a postexposure 
evaluation and follow-up for any worker 
who experiences an occupational 
exposure incident. This should be done 
immediately as postexposure prophylactic 
medications, if needed, should be started 
within a few hours. 

Procedures for evaluating circumstances 
surrounding exposure incidents 

• An exposure incident is a specific eye, 
mouth, other mucous membrane, 
nonintact skin, or parenteral contact 
with blood or OPIM that results from 
the performance of an EMS system 
responder’s duties. 

• The evaluation and follow-up must be 
at no cost to the worker and includes 
documenting the route (s) of exposure 
and the circumstances under which 
the exposure incident occurred. 

° Identifying and testing the 

source individual for HBV, HCV, 
syphilis, and HIV infectivity, if 
the source individual consents or 
the law does not require consent; 


44 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


rapid HIV testing is enforced by 
OSHA 

° Collecting and testing the 
exposed worker’s blood, if the 
worker consents (for baseline) 

° Offering postexposure 
prophylaxis 

° Offering counseling and 
evaluating reported illnesses 
• The healthcare personnel will provide 
a limited written opinion to the 
employer and all diagnoses must 
remain confidential 

5. Communication of hazards to 
employees 

Warning labels must be affixed to 
containers of regulated waste, containers 
of contaminated sharps, contaminated 
equipment that is being shipped or 
serviced, and bags or containers of 
contaminated laundry, except as provided 
in the standard. 5 

6. Provide information and training to 
workers 

Employers must ensure that their workers 
receive regular training that covers all 
elements of the standard. 6 Employers 
must offer this training on initial 
assignment, at least annually thereafter, 
and when new or modified tasks or 
procedures affect a worker’s occupational 
exposure. Annual training differs from 
initial training. Workers must have the 
opportunity to ask the trainer questions. 
Training must be presented at an 
educational level and in a language that 
workers understand. 

7. Recordkeeping 

Medical records relating to exposures 
must be kept for 30 years beyond the 
time of employment. Training records 
must be kept for 3 years. The employer 
also must maintain a Sharps Injury Log, 
unless it is exempt under Part 1904 — 
Recording and Reporting Occupational 


Injuries and Illnesses, in Title 29 of the 
Code of Federal Regulations. 

8 . Creation of a written plan, updated 
annually 

The update must reflect changes in tasks, 
procedures, and positions that affect 
occupational exposure, and technological 
changes that eliminate or reduce 
occupational exposure. In addition, 
employers must annually document in 
the plan that they have considered and 
begun using appropriate, commercially 
available, effective, safer medical devices 
designed to eliminate or minimize 
occupational exposure. Employers 
must also document that they have 
solicited input from frontline workers 
in identifying, evaluating, and selecting 
effective engineering and work practice 
controls. 

9. Infectious diseases prevalent in your 
area 

Another element of an ECP should 
include the infectious diseases prevalent in 
your area. Collaborate and interact with 
your local health department to gather 
this information. Many states post this 
information online. You can also conduct 
a risk assessment to determine which 
diseases to target. The lists included in the 
Ryan White Act are a good starting point. 
Signs and symptoms as well as prevention 
methods should be discussed and updated 
annually. 

Even with your ECP and all the safety nets in 
place, there are going to be times when gloves tear, 
clothes over nonintact skin get soaked with blood, 
or a coughing patient sprays an unprotected 
face. This is when planning comes to fruition, as 
demonstrated by the case study presented here. 

Case Study 

During a search of a suspect in custody, a law 
enforcement officer is stuck deeply by a recently 


Association for Professionals in Infection Control and Epidemiology 45 



Guide to Infection Prevention in Emergency Medical Services 


used, uncapped heroin syringe. In line with the 
Police Agency’s Exposure Control Plan they contact 
the agency DICO/IP who triages the situation, 
advises that the officer needs to report to the local 
emergency room, with the suspect, for a source 
blood draw. The IP reminds the officer that their 
immunization record indicates a Tdap 4 years 
ago and a post-HBV series titer >150 mlU/mL 
(anything >10 mlU/mL is protective against HBV 
acquisition; testing the suspect for HBV is not 
necessary). The suspect consents to HIV, HCV, 
and syphilis testing and is found to be HIV positive 
and HCV negative after testing. The syphilis lab 
is pending. The cost of the suspect’s testing is part 
of the officer’s workers’ compensation case. The 
officer has baseline labs drawn, is counseled, and 
given the first dose of postexposure prophylactic 
antiviral medications within the first several 
hours following exposure. The officer will receive 
follow-up with labs and counseling. The hospital 
IP calls the agency DCIO/IP the next day with 
the syphilis results. With preexisting relationships 
among providers, the facility IP, and agency DICO/ 
IP, appropriate service was provided in a timely 
fashion. Note: this situation also calls for an entry 
on the agency’s sharps log, even though the type of 
device is listed as unknown. Some risk mitigation 
with the officer would be to discuss the inherent 
exposure risk and encourage the use of Kevlar 
gloves during pat downs. 

The Ryan White Act 

The Ryan White HIV/AIDS Treatment 
Extension Act of 2009 (Pub. L. 111-87) addresses 
notification procedures and requirements for 
medical facilities and state public health officers 
and their designated officers regarding exposure 
of emergency response employees (EREs) to 
potentially life-threatening infectious diseases. 5 
The Ryan White Act identifies other infectious 
diseases of concern. 6 The list of potentially life- 
threatening infectious diseases to which EMS 
system responders may be exposed was presented 
previously in this guide. These diseases include 
those caused by any transmissible agent included 


in the Department of Health and Human 
Services (HHS) Select Agents List. Many are 
not routinely transmitted human to human but 
may be transmitted by exposure to contaminated 
environments. The HHS Select Agents List 
is updated regularly and can be found on the 
National Select Agent Registry website: http:// 
www.selectagents.gov/. See Example 6.2 for a list 
of Select Agents as of December 5, 2012. 

The Ryan White Act specifies that medical facilities 
must respond to appropriate requests by making 
determinations about whether EMS system 
responder’s have been exposed to infectious diseases 
as soon as possible but no longer than 48 hours. 

A medical facility has access to two types of 
information related to a potential exposure 
incident to use in making a determination. 

First, the DICO’s request submitted to the 
medical facility contains a “statement of the facts 
collected” about the EMS system responder’s 
potential exposure incident. Information about 
infectious disease transmission provided in 
relevant CDC guidance documents 7 ' 8 ' 9 or in 
current medical literature should be considered 
in assessing whether there is a realistic possibility 
that the exposure incident described in the 
statement of the facts could potentially transmit 
an infectious disease. 

Second, the medical facility possesses medical 
information about the victim of an emergency 
transported and/or treated by the EMS system 
responder. This is the medical information that the 
medical facility would normally obtain according 
to its usual standards of care to diagnose or treat 
the victim, since the Act does not require special 
testing in response to a request for a determination. 
Each state varies in their consent and testing 
requirements so check with your state or local 
health department to determine your process. 

Information about the potential exposure incident 
and medical information about the victim 


46 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


should be used to make one of four possible 
determinations (see http://www.cdc.gov/niosh/ 
topics/ryanwhite/ for easy-to-follow flow charts 
with procedures for notification of possible 
exposure to infectious diseases). 

1. The EMS system responder involved 
has been exposed to an infectious 
disease included on the list. 

Facts provided in the request document 
a realistic possibility that an exposure 
incident occurred with potential for 
transmitting a listed infectious disease 
from the victim of an emergency to the 
involved EMS system responder; and the 
medical facility possesses sufficient medical 
information allowing it to determine that 
the victim of an emergency treated and/or 
transported by the involved EMS system 
responder had a listed infectious disease 
that was possibly contagious at the time of 
the potential exposure incident. 

2. The EMS system responder involved 
has not been exposed to an infectious 
disease included on the list. 

Facts provided in the request rule out 
a realistic possibility that an exposure 
incident occurred with potential for 
transmitting a listed infectious disease 
from the victim of an emergency to 
the involved EMS system responder; 
or the medical facility possesses 
sufficient medical information allowing 
it to determine that the victim of an 
emergency treated and/or transported by 
the involved EMS system responder did 
not have a listed infectious disease that 
was possibly contagious at the time of the 
potential exposure incident. 

3. The medical facility possesses no 
information on whether the victim 
involved has an infectious disease 
included on the list. 

The medical facility lacks sufficient 
medical information allowing it to 


determine whether the victim of an 
emergency treated and/or transported by 
the involved EMS system responder had, 
or did not have, a listed infectious disease 
at the time of the potential exposure 
incident. 

If the medical facility subsequently 
acquires sufficient medical information 
allowing it to determine that the 
victim of an emergency treated and/or 
transported by the involved EMS system 
responder had a listed infectious disease 
that was possibly contagious at the time 
of the potential exposure incident, then it 
should revise its determination to reflect 
the new information. 

4. The facts submitted in the request are 
insufficient to make the determination 
about whether the EMS system 
responder was exposed to an infectious 
disease included on the list. 

Facts provided in the request 
insufficiently document the exposure 
incident, making it impossible to 
determine if there was a realistic 
possibility that an exposure incident 
occurred with potential for transmitting 
an infectious disease included on the list 
from the victim of an emergency to the 
involved EMS system responder. 

Good relationships with your area hospitals 
will expedite the process for an EMS system 
responder to be seen and have a source patient’s 
blood drawn. (Note that the source patient is 
never charged for the lab work requested by your 
agency and the request must be in writing. It 
is the agency’s financial responsibility. In some 
jurisdictions the cost of the source patient labs 
becomes part of the workers’ compensation case of 
the exposed/injured EMS system responder.) 

All treatment for postexposure management 
should follow the recommendations. See Figures 
6.6 to 6.14 for algorithms of postexposure 
management guidelines for hepatitis B (known 


Association for Professionals in Infection Control and Epidemiology 47 



Guide to Infection Prevention in Emergency Medical Services 


responder, anti-HBs >10 IU/mL; unvaccinated 
and source unknown; known and vaccinated 
nonresponder; vaccine response unknown), 
hepatitis C, HIV, and TB and anthrax 
(inhalation and cutaneous) set forth by the CDC 
guidelines, June 2001, October 2001, September 
2005, December 2005, and August 2008 or 
more recent updated CDC guidelines. EMS 
agencies can develop postexposure guidelines and 
flow charts such as these examples from the CDC 
guidelines. 

Program models 

In one area of the country, five public 
service agencies have pooled their resources 
(occupational health nurses) for after-hours 
triage of exposure incidents. All agencies have 
widely disseminated an exposure control contact 
phone number to be used by employees in the 
event of an occupational exposure. The number 
is answered by an answering service who then 
pages the DICO (or on-call RN). That DICO 
calls the worker to determine the specifics of 
the exposure and then completes a standard 
form (see Examples 6.3 and 6.4). NFPA 1581, 
Standard on Fire Department Infection Control 
Program, 2005 edition, also has an example of 
a sample exposure report. If the employee needs 
to be seen at a hospital, the DICO calls ahead 
to the emergency room with basic information 
and request for source testing, if consent can 
be obtained. If the situation warrants, the 
hospital or infectious disease physician starts the 
employee on postexposure prophylaxis. Each 
agency follows up with their employee. 

Note: A standard two-drug postexposure 
prophylaxis regime can cost as much as $2000 for 
the required 28-day supply. In your preplanning 
discussions, consider asking the provider to 
write the first prescription for 3 to 7 days, as the 
regime is not always tolerated well and one of 
the drugs may be stopped. The individual placed 
on postexposure prophylaxis should be seen and 
evaluated at 72 hours. 


Many agencies utilize Field Operations Guides 
(FOG) as a checklist for action in an exposure 
incident. See Example 6.5. 

Special situations/concerns 

• In an officer-involved shooting, the officer 
is typically not immediately available to 
the DCIO/IP. Ensure someone in the 
command structure has on their checklist 
to determine if the officer experienced 

a blood or tissue exposure. If so, they 
should notify the DICO/IP so source 
testing can be requested of the hospital or 
medical examiner. 

• Agencies should have a specific plan 
for cleaning blood and OPIM from 
patrol cars and transport vehicles. If 
inmate workers are used, they and their 
supervisors should be trained in exposure 
control methods and proper use of PPE. 

• Fire departments are sometimes requested 
to “wash down” a scene on public 
property that has blood and OPIM. 

A safer response would be a protocol 
involving absorbent pads and appropriate 
PPE. The reason for this is to prevent 
the introduction of large amounts of 
biological material into waterways 
that may cause pollution concerns and 
increased exposure risks if blood splatters 
onto EMS system responders. 

• Clearing homeless camps should follow 
a standard procedure to decrease the risk 
of exposure to rodents, human waste, 
infested bedding, needles, and booby- 
traps. 

• There are situations in which the patient 
is not transported to the hospital. The 
patient may be pronounced dead at the 
scene or refuse transport. The coroner 
or medical examiner is responsible for 
ensuring the deceased source patient’s 
blood is drawn in a postexposure event. 
Many states have statutes and procedures 


48 Association for Professionals in Infection Control and Epidemiology 



Guide to Infection Prevention in Emergency Medical Services 


in place and a close cooperative 
working agreement with the medical 
examiner’s office can provide the efficient 
completion of postexposure testing of 
the deceased patient. The process in 
some states requires a signed affidavit 
attesting to the circumstances of the 
exposure. After review by the local 
health authority, the source patient can 
be traced and requested to submit to 
testing. There are also provisions for 
court-ordered testing should a voluntary 
attempt be unsuccessful. 

• On occasion, police, correctional facility 
officers, and other emergency system 
responders are intentionally bitten 
by suspects or prisoners. When such 
bites occur, routine medical treatment 
(including assessment of tetanus status) 
should be implemented as soon as 
possible, since bites can result in infection 
with organisms other than HIV and 
HBV. 

Cited References 

1 Occupational transmission of Neisseria meningitidis- 
California 2009. MMWR Recomm Rep Nov 19 

2010;59(45): 1480-1483. 

2 Harris S, Nicolai L. Occupational exposures in 
emergency medical service providers and knowledge 
of compliance with universal precautions. Am J Infect 
Control 2010;38:86-94. 

3 Carrico R, ed. APIC text of infection control and 
epidemiology. Washington, DC: Association for 
Professionals in Infection Control and Epidemiology, 
Inc., 2009; chapter 113. 


4 OSHA. Occupational exposure to blood borne 
pathogens precautions for emergency responders, OSHA 
3130 (Revised) 1998. Available at: http://www. 
osha.gov/pls/oshaweb/owadisp.show_document?p_ 
table=standards&p_id= 10051. Accessed January 24, 
2013. 

5 Federal Register Nov 2 2011;RWCA76(212). 

6 Federal Register Nov 2 201 l;RWCA76(212):6774l. 

7 Siegel JD, Rhinehart E, Jackson M, Chiarello L, 

The Healthcare Infection Control Practices Advisory 
Committee. The guideline for isolation precautions: 
preventing transmission of infectious agents in healthcare 
settings 2007. Available at: http://www.cdc.gov/hicp 
ac/2007ip/2007isolationprecautions.html. Accessed 
December 13, 2012. 

8 Implementation of Section 2695 (42 USC 300ff- 
131) of Public Law 111-87: Infectious Diseases and 
Circumstances Relevant to Notification Requirements. 
FederalRegisterNov 2 2011;76(212). Available at: 
http: //www.cdc.gov/niosh/topics/ryanwhite/pdfs/ 
FRNll-2-2011GPO.pdf. Accessed January 24, 2013. 

9 CDC. Bloodborne pathogens and aerosols. Available at: 
http: //www.cdc.gov/oralhealth/infectioncontrol/faq/. 
Accessed January 24, 2013. 

Additional Resources 

Northwest AIDS Education and Training Center. 
Reproducible guide for postexposure prophylaxis 
for Occupational Bloodborne Exposures. Available 
at: http://depts.washington.edu/nwaetc/resources/ 
PEPManual.pdf 

North Dakota Ambulance Service Exposure Control 
Plan. Available at: http://www.ndhealth.gov/EMS/ 
Protocol.htm 


Association for Professionals in Infection Control and Epidemiology 49 



Guide to Infection Prevention in Emergency Medical Services 
Example 6.1 


EXPOSURE DETERMINATION 

A. Employees with Potential for Occupational Exposure to BBP 

The following categories of employees employed by the fire department are considered to have risk of 
occupational exposure to BBP: 

1. All line personnel: All individuals in this class have a potential for occupational exposure. This includes all 
line firefighters, individuals that work a 40-hour week and work call-shifts, and administrative personnel 
that are involved in or present during ongoing fire and rescue services provided by the department. 


The following job classifications are included in this category: 


a. 

Chief 

b. 

Division Chiefs 

c. 

Deputy Chiefs 

d. 

Fire Battalion Chiefs 

e. 

Fire Captains 

f. 

Fire Lieutenants 

g- 

Firefighters 

h. 

Fire Investigators 

i. 

Fire Inspectors 

)■ 

EMS Specialists 


Support Personnel: Other personnel who could have occupational exposure include: 


a. 

EMS support personnel 

b. 

Occupational Health Coordinator 

c. 

Hazardous Materials Coordinator 

d. 

Emergency Vehicle Technicians, delivery 
and shop personnel 


B. Incidents and Procedures with Potential for Occupational Exposure 


1. Firefighter/EMTs are involved in many types of incidents which have potential for occupational 
exposure. These incidents include, but are not limited to: 


a. 

Fires 

b. 

Extrications 

c. 

Forcible entries 

d. 

Water rescue 

e. 

Explosions 

f. 

Emergency medical calls 

g- 

Social problem intervention 

h. 

Hazmat related calls and disposition 

i. 

Scene clean up, decontamination, and 
disposal 




50 Association for Professionals in Infection Control and Epidemiology 






Guide to Infection Prevention in Emergency Medical Services 


EXPOSURE DETERMINATION, continued 

2. Tasks performed during or following emergency response incidents which could involve exposure 
include but are not limited to: 



Task 

Gloves 

Protective 

eyewear 

Mask 

Gown 

a. 

Airway management/intubation/suction 

Yes 

Yes 

Yes 

No 

b. 

Starting IVs/IOs 

Yes 

No 

No 

No 

c. 

Trauma, dressing wounds 

Yes 

Yes 

Yes 

Yes 

d. 

Obtaining blood samples 

Yes 

No 

No 

No 

e. 

Public assist calls 

Yes 

No 

No 

No 

f. 

Moving, evaluating, or treating patients 

Yes 

No 

No 

No 

g- 

Administering medications 

No 

No 

No 

No 

h. 

Performing CPR/mouth-to-mouth resuscitation 
(if off-duty and no barrier device was available) 

Yes 

No 

No 

No 

i. 

Handling, cleaning, and disposing of 
contaminated equipment or materials 

Yes 

Yes 

No 

^Varies 

)■ 

Extrication/trauma 

Yes 

Yes 

Yes 

^Varies 


* Depending on volume of bodily fluids present 

Source: CDC. 2007guideline for isolation precautions: preventing transmission of infectious 
agents in healthcare settings. Available at: http://www.cdc.gov/hicpac/2007IP/2007ip_table4. 
html. Accessed January 24, 2013. 


Association for Professionals in Infection Control and Epidemiology 51 






Guide to Infection Prevention in Emergency Medical Services 

Example 6.2 


SELECT AGENTS AND TOXINS 

The following biological agents and toxins have been determined to have the potential to pose a severe threat to both human and 

animal health, to plant health, or to animal and plant products. An attenuated strain of a select agent or an inactive form of a select 

toxin may be excluded from the requirements of the Select Agent Regulations. The list of excluded agents and toxins can be found at: 

http: //www. selectagents. gov 

HHS SELECT AGENTS AND TOXINS 

OVERLAP SELECT AGENTS AND TOXINS 

Abrin 

Bacillus anthracis 

Botulinum neurotoxins 

Bmcella abortus 

Botulinum neurotoxin producing species of Clostridium 

Bmcella melitensis 

Cercopithecine herpesvirus 1 (Herpes B virus) 

Bmcella suis 

Clostridium perfringens epsilon toxin 

Burkholderia mallei (formerly Pseudomonas mallei) 

Coccidioides posadasii/Coccidioides immitis 

Burkholderia pseudomallei (formerly Pseudomonas 

Conotoxins 

pseudomallei) 

Coxiella burnetii 

Hendra virus 

Crimean-Congo hemorrhagic fever virus 

Nipah virus 

Diacetoxyscirpenol 

Rift Valley fever virus 

Eastern Equine Encephalitis virus 

Venezuelan Equine Encephalitis virus 

Ebola virus 

Francisella tularensis 

USDA VETERINARY SERVICES SELECT AGENTS 

Lassa fever virus 

African horse sickness virus 

Marburg virus 

African swine fever virus 

Monkeypox virus 

Akabane virus 

Reconstructed replication competent forms of the 1918 

Avian influenza virus (highly pathogenic) 

pandemic influenza virus containing any portion of the 

Bluetongue virus (exotic) 

coding regions of all eight gene segments (Reconstructed 

Bovine spongiform encephalopathy agent 

1918 Influenza virus) 

Camel pox virus 

Ricin 

Classical swine fever virus 

Rickettsia prowazekii 

Ehrlichia ruminantium (Heartwater) 

Rickettsia rickettsii 

Foot-and-mouth disease virus 

Saxitoxin 

Goat pox virus 

Shiga-like ribosome inactivating proteins 

Japanese encephalitis virus 

Shigatoxin 

Lumpy skin disease virus 

South American Hemorrhagic Fever viruses 

Malignant catarrhal fever virus 

Flexal 

(Alcelaphine herpesvirus type 1) 

Guanarito 

Menangle virus 

Junin 

Mycoplasma capricolum subspecies capripneumoniae 

Matchupo 

(contagious caprine pleuropneumonia) 

Sabia 

Mycoplasma mycoides subspecies mycoides small 

Staphylococcal enterotoxins 

colony (MmmSC) (contagious bovine pleuropneumonia) 
Peste des petits ruminants virus 

T-2 toxin 

Rinderpest virus 

Tetrodotoxin 

Sheep pox virus 

Tick-borne encephalitis complex (flavi) viruses 

Swine vesicular disease virus 

Central European Tick-borne encephalitis 

Vesicular stomatitis virus (exotic): Indiana subtypes 

Far Eastern Tick-borne encephalitis 

VSV-IN2, VSV-IN3 

Kyasanur Forest disease 

Virulent Newcastle disease virus 1 

Omsk Hemorrhagic Fever 

Russian Spring and Summer encephalitis 

USDA PLANT (PPQ) SELECT AGENTS 

Variola major virus (Smallpox virus) 

Peronosclerospora philippinensis 

Variola minor virus (Alastrim) 

Phoma glycinicola (formerly Pyrenochaeta Yersinia pestis glycines) 

Yersinia pestis 

Ralstonia solanacearum race 3, biovar 2 

Rathayibacter toxicus 

Sclerophthora rayssiae var. zeae 

Synchytrium endobioticum 

Xanthomonas oryzae 

Xylella fastidiosa (citrus variegated chlorosis strain) 

1 A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral pathogenicity index in day-old chicks ( Callus 

gallus) of 0.7 or greater or has an amino acid sequence at 

the fusion (F) protein cleavage site that is consistent with virulent strains 

of Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a 

| virulent virus. 



52 Association for Professionals in Infection Control and Epidemiology 





Guide to Infection Prevention in Emergency Medical Services 


Example 6.3 

Communicable Disease Guidelines 


Exposure Description 

Action Required 

Exposure of open skin, cuts, or breaks or 
mucous membranes, such as eyes, nose, 
or mouth to blood or body fluids. This 
includes needlesticks and human bites. 

Clean exposed area with soap and large amounts of water; 
if in the mouth, rinse and spit repeatedly; flush eyes as 
appropriate. Provide first aid if needed. Call your DICO. 


When calling the Exposure Control Line DICO, establish a procedure that is appropriate for the agency 
and setting. This should be addressed in the ECP. 

• Identify self and your agency 

• State issue briefly 

• Give your call back number 

• If not contacted by the DICO within 20 minutes, call the Exposure Control Line again 

It is helpful if you have information about the “source person” you were in contact with and call as soon 
as possible, preferably from the emergency department where the patient was delivered. 

• Name 

• Date of birth 

• Their location/contact information 


Association for Professionals in Infection Control and Epidemiology 53 




Guide to infection Prevention in Emergency Medical Services 
Example 6.4 


Occupational Exposure Worksheet 


Caller name: _ 

Employee name: _ 

Employer: _ 

Phone: (w)_ (h)_ 

Any other agencies responding to same incident? 

Type of Exposure: □ ID □ HAZMAT 

□ Mucous membrane_ 

□ Needle/sharp_ 

□ Open skin_ 

□ Intact skin_ 

□ Respiratory _ 

□ Clothes/equip _ 

□ Airborne _ 

□ Other _ 


Date: _Time: 

Exposure date: _ 

Exposure time:_ 

_(c)_ 


Source of Exposure: 

□ Blood _ 

□ Vomit _ 

□ Urine _ 

□ Saliva _ 

□ Feces_ 

□ Respiratory _ 

□ Smoke_ 

□ Other _ 


Narrative of exposure incident: 


Precautions: 




□ Eyewear □ Mask 

□ SCBA 

□ Turnouts □ Gloves □ Other 

Immunizations: 


Counseling Issues 


□ HepB Vacc Date: 


□ HIV stats 

□ PEP 

□ Titer Date: 


□ HepB 

□ Hep C 

□ Tetanus Date: 


□ Standard Prec 

□ Risks 

□ Tb Date: 


□ Blood donation 

□ Sex 

□ Other: 


□ Tb/Airborne 

□ Meningitis 


54 Association for Professionals in Infection Control and Epidemiology 





Guide to Infection Prevention in Emergency Medical Services 

Occupational Exposure Worksheet, continued 

Source Patient: 

Name: _Labs:_ 

Location:_Contact: _ 

DOB: _Phone: _ 

Source Consent obtained:_Court order process Initiated: _ 

Source testing confirmed:_ 

Results: _ 

Assessment/Treatment/Recommendations: 

□ PEP □ Hep B Booster □ Tb test □ Tetanus □ Hep A □ Meningitis-Cipro 

□ Other:_ 

Call taken by: _ 

Signature, Healthcare Provider 

Notes 


Association for Professionals in Infection Control and Epidemiology 55 




Guide to Infection Prevention in Emergency Medical Services 

Example 6.5 


Blood and Body Fluid Exposure 
Field Operations Guide (FOG) 

Any of the following events will be considered a bloodborne exposure and require the DICO 
(Designated Infection Control Officer) to follow all steps outlined here. 

1. Blood or amniotic fluid splash to the eyes, nose, or mouth. 

2. Blood or amniotic fluid comes in contact with nonintact skin. 

3. Contaminated needlestick. 

4. Blood or amniotic fluid soaked clothing over nonintact skin. 

The DICO will complete the following steps immediately and initial each box as completed. 

□ Upon dispatch contact unit and verify progress of source patient blood testing. 

□ Verify decontamination has been completed by the exposed employee. 

□ Place the unit out of service upon completion of the call. 

□ Contact supervisor to advise of the exposure and confirm the dispatch of the DICO. 

The DICO will complete the following steps as soon as possible after the exposure and initial each box 
as completed. 

□ Contact hospital for source patient testing. 

□ Have source blood sample drawn by authorized medical personnel. 

□ Verify exposed employee gets follow-up counseling and treatment, if required. 

During the course of the FOG either the DICO or EMS Field Supervisor will contact the unit OIC 
(officer in charge) to determine destination and provide further instructions. This completed form will 
be presented to the DICO upon arrival. 


56 Association for Professionals in Infection Control and Epidemiology 






Guide to Infection Prevention in Emergency Medical Services 


Figure 6.1. Postexposure HBV Prophylaxis: Known Responder* 

(*a responder has adequate levels of serum antibody to HBsAG [i.e., anti-HBs > 10 mlU/mL]). 


Test Source 
Patient 


Source Positive 
for HBV 


t 

Check Employee 
Medical File 


Source Negative 
for HBV 



No Treatment 


t 

Positive Titer 
on File 

-► 

No Treatment 



CDC. MMWR, June 29, 2001, Sept. 30, 2005, August 1, 2008 

http://www.mpaetc.org/downloads/PEP%201inal%20(2006).pdf 

http://www.cdc.gov/MMWR/preview/mmwrhtml/rr5706al.htm 


Association for Professionals in Infection Control and Epidemiology 57 













Guide to Infection Prevention in Emergency Medical Services 


Figure 6.2. Postexposure HBV Prophylaxis: Nonvaccinated Employee or Source Unknown 


Source 

Negative 


Test Source 
Patient or 
Unknown Source 



Source Positive 



Start Vaccine 

Give HB1G xl and 

Series 

Start Vaccine 


Series 


CDC, MMWR, June 29, 2001, Sept. 30, 2005, August 1, 2008 

http://www.mpaetc.org/downloads/PEP%20final%20(2006).pdf 
http: / / www. cdc. gov/MMWR/preview/ mmwrhtml/rr5706a 1 .htm 


Figure 6.3. Postexposure HBV Prophylaxis: Known Vaccine Nonresponder 


Test Source 
Patient 


Source 
Negative for 
HBV 



Source Positive 
for HBV 



No Treatment 

Give HB1G xl And 
Revaccinate Or 


HB1G x2 Doses 


CDC, MMWR, June 29, 2001, Sept. 30, 2005, August 1, 2008 

http://www.mpaetc.org/downloads/PEP%20final%20(2006).pdf 
http://www.cdc.gov/MMWR/preview/ mmwrhtml/rr5706a 1 .htm 


58 Association for Professionals in Infection Control and Epidemiology 
















Guide to Infection Prevention in Emergency Medical Services 


Figure 6.4. Postexposure HBV Prophylaxis: Vaccine Response Unknown 

Test Source 



CDC, MMWR, June 29, 2001, Sept. 30, 2005, August 1, 2008 

http://www.mpaetc.org/downloads/PEP%20final%20(2006).pdf 
http://www.cdc. gov/MMWR/preview/mmwrhtml/rr5706al.htm 


Association for Professionals in Infection Control and Epidemiology 59 











Guide to Infection Prevention in Emergency Medical Services 


Figure 6.5. Post HCV Exposure Prophylaxis 


Source 
Negative for 
HCV 


t 


No Treatment 


Test Source 
Patient 



Source Positive 
for HCV 



Refer for medical 
management to a 
knowledgeable specialist 


CDC, MMWR, June 29, 2001, Sept. 30, 2005, August 1, 2008 

http://www.mpaetc.org/downloads/PEP%20final%20(2006).pdf 
http: / / www. cdc. gov/MMWR/preview/ mmwrhtml/rr5706a 1 .htm 


60 Association for Professionals in Infection Control and Epidemiology 










Guide to Infection Prevention in Emergency Medical Services 


Figure 6.6. Post HIV Exposure Prophylaxis 



No Treatment 


Test Source 
Patient 




HIV postexposure prophylaxis (PEP) should be started ASAP and preferably within hours. If this is delayed more than 
24 to 36 hours, seek expert consultation. PEP should continue for 28 days. Consult an expert for the recommended 
HIV PEP drug regimen. If information on the source patient is unknown, and the decision to start PEP is made (based 
on risk factors, exposure type, etc.), PEP should not be delayed; changes can be made as needed after PEP is started. The 
exposed EMS system responder should be reevaluated within 72 hours as additional information about the source patient 
is obtained. If source patient is found to be HIV-negative, PEP should be discontinued. 

PEP Resources 

National Clinicians’ Post-exposure Prophylaxis Hotline (PEPline) 1-888-448-4911 

CDC, MMWR, June 29, 2001, Sept. 30, 2005, August 1, 2008 

http://www.mpaetc.org/downloads/PEP%20final%20(2006).pdf 
http: / / www.cdc.gov/MMWR/preview/mmwrhtml/rr5706a 1 .htm 


Association for Professionals in Infection Control and Epidemiology 61 









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Figure 6.7. Post Tuberculosis Exposure Prophylaxis 



CDC, MMWR, December 16, 2005 

http://www.cdc.gov/ mmwr/preview/mmwrhtml/rr5415a4.htm 


62 Association for Professionals in Infection Control and Epidemiology 











Guide to Infection Prevention in Emergency Medical Services 


Figure 6.8. Post Anthrax (Inhalation) Exposure Prophylaxis 


Nasal swabs can 
occasionally 
document 
exposure, but 
cannot rule out 
exposure to 
B. anthracis 


Test Source 
Patient exposed 


t 

Source 

Negative/Positive 

Antimicrobial 

Prophylaxis 

administered 


t 


Ciprofloxacin 400 
mg every 12 
hours* 

OR 


t 


Doxycycline 100 mg every 12 hours' 1 
and 

One or two additional antimicrobial 


CDC, MMWR, October 26, 2001 

http: / / www. cdc. gov/mmwr/preview/mmwrhtml/mm5042a 1 ,htm 


* For gastrointestinal and oropharyngeal anthrax, use regimens recommended for inhalation anthrax. 
f Other agents with in vitro activity include rifampin, vancomycin, penicillin, ampicillin, chloramphenicol, imipenem, 
clindamycin, and clarithromycin. Because of concerns of constitutive and inducible beta-lactamases in Bacillus anthracis , 
penicillin should not be used alone. Consultation with an infectious disease specialist is needed. 
n If meningitis is suspected, doxycycline may be less optimal because of poor central nervous system penetration. 


Association for Professionals in Infection Control and Epidemiology 63 












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Figure 6.9. Post Anthrax (Cutaneous) Exposure Prophylaxis 

Test Source 
Patient exposed 


t 

Source 

Negative/Positive 

Antimicrobial 

Prophylaxis 

administered 


t 


CDC, MMWR, October 26, 2001 

http: / / www. cdc. gov/mmwr/preview/mmwrhtml/mm5042a 1 ,htm 


Doxycycline 100 mg every 12 hours' 1 
and 

One or two additional antimicrobial 


Antimicrobial 
treatment may 
render lesions 
culture negative 
in 24 hours; 
corticosteroids 
may be considered 
for extensive 
edema or swelling 
of the head and 
neck region 



Ciprofloxacin 400 
mg every 12 
hours* 

OR 


* Cutaneous anthrax with signs of systemic involvement, extensive edema, or lesions on the head or neck require intravenous 
therapy, and a multidrug approach is recommended. 

f Other agents with in vitro activity include rifampin, vancomycin, penicillin, ampicillin, chloramphenicol, imipenem, 
clindamycin, and clarithromycin. Because of concerns of constitutive and inducible beta-lactamases in Bacillus anthracis, 
penicillin should not be used alone. Consultation with an infectious disease specialist is needed. 
n If meningitis is suspected, doxycycline may be less optimal because of poor central nervous system penetration. 


64 Association for Professionals in Infection Control and Epidemiology 












Guide to Infection Prevention in Emergency Medical Services 


Section 7: Bioterrorism and Infectious 
Disease Emergency Preparedness 


Bioterrorism 

Bioterrorism refers to the use of biological agents on 
civilian or military populations, animals, or crops. A 
combination of factors have raised concerns about 
the actual use of bioterrorism agents, including 
the breakup of the former Soviet Union and the 
concomitant dispersal of scientists and agents 
involved in bioterrorism research, the rise of radical 
groups focused on destroying what they believe to 
be evil forces, and the discovery of Iraq’s stockpiled 
anthrax, botulinum toxin, and other biological 
warfare agents. There are a broad range of potential 
bioterrorism agents, including bacteria, viruses, and 
other toxins of microbial, plant, or animal origin. 

Nature of the bioterrorism 
threat 

The most likely route of dissemination is an 
aerosolized release of 1 to 5 pm particles. Other 
methods of dissemination include oral (intentional 
contamination of food/water supply), percutaneous, 
infected animal vector (e.g., release of infected 
fleas), and human-to-human spread (individual 
infected with communicable disease walking 
among a crowd of healthy people). Other possible 
distribution methods, such as mailing a letter or 
package containing infectious particles, may also be 
feasible. 

Pandemics 

A pandemic is a large-scale outbreak that affects at 
least two continents. Unlike a bioterrorism attack 
or outbreak of an emerging infection, a pandemic 
is usually not an event that occurs suddenly, 
although a pandemic can strike without warning, 


as evidenced by the 2009 H1N1 pandemic. The 
World Health Organization (WHO) describes 
six phases of a pandemic, starting with the period 
in which there are few to no human cases from 
the organism/disease to the period in which 
there is efficient and sustained disease spread 
from person to person. The six WHO pandemic 
phases are outlined in Table 7.1. Pandemics are 
expected to hit communities in multiple waves, 
each lasting approximately 6 to 8 weeks, making 
response a more prolonged event than with other 
types of disasters. Each pandemic wave will cause 
significant patient surge, including an increased 
need for emergency medical services. During an 
influenza pandemic, attack rates will likely be 
between 15 and 35 percent across all populations; 
young children and the elderly are expected to be 
disproportionately affected and have attack rates 
close to 40 percent. 


Table 7.1. The six phases of pandemic 


Phase 

Description of the phase 

1 

Low risk of human cases 

2 

Higher risk of human cases 

3 

No or very limited human-to-human 
transmission 

4 

Evidence of increased human-to-human 
transmission 

5 

Evidence of significant human-to-human 
transmission 

6 

Efficient and sustained human-to-human 
transmission 


Adapted from World Health Organization. Current WHO 
phase of pandemic alert 2008. Available at: http://www. 
who. int/topics/avian_influenza/en/ 


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There are a number of agents that could cause 
a pandemic, including SARS and plague. 
Historically, influenza has caused the most 
pandemics and is expected to cause others in the 
future. One of the most recent pandemic threats 
has been H5N1, a strain of influenza A also called 
“avian influenza.” 

Nature of the pandemic threat 

As of December 2012, WHO indicates that we 
are in pandemic phase 3: there is an agent with the 
capacity to cause a pandemic (influenza A/H5N1), 
but there is currently no or very limited human-to- 
human transmission. There have been 610 human 
cases and 360 deaths from H5N1 avian influenza as 
of December 2012. It is not known whether H5N1 
will continue to mutate and adapt to become more 
easily spread from person to person, resulting in a 
pandemic. It is also possible that another strain or 
organism could emerge and cause a pandemic. A 
future influenza pandemic is considered inevitable, 
but it is not known what strain will be involved or 
when the event will occur. 

Infection prevention 
procedures 

The amount of DICO involvement in disaster 
response depends on the agent involved. In an 
infectious disease disaster, involvement will be 
critical, especially if the agent is communicable. 
Many agents of bioterrorism are not transmitted 
from person to person, but some are. Most 
emerging infectious diseases are communicable, 
but a few are not. 

Bioterrorism agents and emerging infectious 
diseases that are communicable pose the greatest 
risk to society. Examples of potential infectious 
disease disasters that involve communicable 
diseases include pneumonic plague, smallpox, viral 
hemorrhagic fever viruses, SARS, and pandemic 
influenza. In these instances, infection prevention 
will be essential to control the outbreak, prevent 
future cases, and decrease morbidity and mortality 
associated with the event. 


Isolation, personal protective 
equipment, and hand hygiene 

In addition to pharmacological interventions 
(anti-infective therapy, chemoprophylaxis, and 
vaccination), nonpharmacological interventions 
should be implemented to prevent and control 
disease spread during an infectious disease disaster. 
The primary nonpharmacological interventions 
involve isolation, PPE, and hand hygiene use as 
discussed previously in this guide. In regard to 
bioterrorism, the exact necessary infection prevention 
procedures cannot be estimated before an attack 
occurs. It depends on many factors, including 
how soon the release is detected (i.e., whether 
decontamination and prophylaxis are necessary), 
how soon the diagnosis is made, how soon 
appropriate isolation was initiated (i.e., the number 
of affected individuals), and what agent was used 
(i.e., whether the agent is contagious). Hand hygiene 
will be essential during any infectious disease disaster, 
and will aid in disease spread as well as protecting 
EMS personnel from exposure and illness. 

Any time a bioterrorism-related or emerging 
infectious disease is suspected, infection prevention 
guidelines for that specific agent/disease should 
be followed. At the beginning of an infectious 
disease disaster when the agent may not have been 
identified or when there is not enough evidence 
to determine the disease transmission route, EMS 
system responders and DICOs need to base infection 
prevention decisions for patient care on syndromes 
and symptomology. This is referred to as syndrome- 
based isolation/control measures. These measures 
are especially important during an infectious disease 
disaster involving a newly emerging infection because 
there may be limited or no information available on 
the causative agent. Table 7.2 outlines the isolation 
categories and control measures to be used based on 
syndromes and symptomology. 

SARS was an example of this situation. When 
SARS first emerged in 2003, the causative agent 
was unknown, as was the transmission route and 
control measures needed to prevent disease spread. 
Infection prevention decisions were made on 


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Table 7.2. Isolation categories and control measures to be used based on syndromes and 
symptomology 


Symptoms/syndrome 

Isolation precaution category* ,b 

Respiratory 


Cough, runny nose, watery eyes 

Droplet 

Fever (>101.1°F) and cough in adults c 

Droplet 

Fever (>101.1°F) and cough in children 3 

Droplet 


Contact 

Fever (>101.1°F), cough with bloody sputum, and weight loss 

Airborne and Contact, plus eye protection when 

or with upper lobe pulmonary infiltrate in an HIV-negative 

performing aerosol-generating procedure 

patient or any lobe of an HIV+ patient 3 


Fever (>101.1°F), cough, and pulmonary infiltrate in any lobe 

Airborne and Contact, plus eye protection 

in patient with a travel history to country with active cases of 


SARS or avian influenza within past 10 to 21 days 1 


Diarrhea and vomiting 


Vomiting 

Standard 

Acute diarrhea with likely infectious cause in an incontinent or 

Contact 

diapered patient 


Watery or explosive stools, with or without blood 

Contact 

Skin 


Fever (>101.1°F) and rash 

Airborne 

Fever (>101.1°F), upper chest rash, and stiff/sore neck 

Droplet 

Eye infections (drainage from eye) 

Standard 

Draining wound/lesion that cannot be covered 

Contact 

Rash 


Itchy rash without fever 

Contact 

Petechial/ecchymotic with fever 

Droplet for 24 hours of antimicrobial therapy 

Rash and positive history of travel to an area with a current 

Droplet and Contact, plus eye protection (goggles 

outbreak ofVHF in the 10 days before fever onset 

or face shield). Add N95 or equivalent when 


performing aerosol-generating procedures. 

Maculopapular with cough, coryza, and fever 

Airborne 

Vesicular, especially if centrifugal in pattern 

Airborne and Contact 


“Always use Standard Precautions. 

b If the causative agent is known, the appropriate isolation precautions for that disease should be used. 

C A temperature of 100°F should be used as the identifier for potential infection to identify the elderly or immunocom¬ 
promised individuals whose physiological changes tend to mask normal signs of infection. In addition, clinical judgment 
should always be used. 

Adapted from Rebmann T, Wilson R, Alexander S, et al. Infection prevention and control for shelters during disasters. Wash¬ 
ington, DC: Association for Professionals in Infection Control and Epidemiology; 2008. Available at: http://www.apic. 
org and Siegal JD, Rhinehart E, Jackson M, et al., and the Healthcare Infection Control Practices Advisory Committee. 
Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings 2007. Available at: http:// 
www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf 


the basis of patients’ symptoms, epidemiological 
information as it became available, and basic 
infection prevention principles. 

During an infectious disease disaster in which 
hospitals will be lull and potentially contagious 
patients may be triaged to alternate care sites, 


emergency responder agencies should consider 
educating the public regarding how to implement 
basic infection prevention strategies in nonhospital 
settings. This may include isolation and PPE 
use in long-term care, alternate care sites, home 
health, medical clinics, community-based 
evacuation shelters, and any other care sites 


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that administers healthcare services or houses 
potentially contagious patients. 

Healthcare personnel surge 
capacity 

EMS agencies, organizations, and businesses, 
including healthcare, should expect high absenteeism 
rates during an infectious disease disaster. 
Absenteeism is expected to be higher during an 
infectious disease disaster than other types of mass 
casualty events. Up to 20 percent of the workforce 
may be affected by illness at the same time during 
a pandemic, and others will be unable or unwilling 
to work due to family obligations or fear. WHO 
recommends that emergency managers plan for 
a 40 percent absenteeism rate during the peak of 
pandemic. Healthcare personnel are expected to be 
infected at the same rate as the general population 
during an infectious disease disaster, which will 
further reduce EMS agencies’ ability to respond to 
such an event. EMS agencies need to plan for this 
increase in healthcare personnel absenteeism. Some 
recommended ways for increasing healthcare worker 
surge capacity include the following: 

• Having back-up contracts for obtaining 
extra staff 

• Providing incentives to acquire and retain 
staff 

• Prioritizing EMS personnel for anti- 
infective therapy, prophylaxis, and 
vaccination 

• Offering anti-infective therapy, 
prophylaxis, and vaccination to family 
members of EMS personnel 

Protection of emergency 
medical services personnel 

EMS personnel will be at high risk of exposure 
during an infectious disease disaster. Policies and 
procedures must be in place to protect EMS from 
exposure and minimize the risk of infection. 

One option is to provide pre-event vaccination 
to EMS professionals. Beginning in 2009, the 


CDC recommended that emergency response 
agencies consider offering staff the anthrax vaccine 
series pre-event as a way of protecting workers 
of exposure following an anthrax bioterrorism 
attack. Other pre-event vaccinations, such as 
seasonal influenza, should also be offered to 
EMS professionals to provide protection during 
an infectious disease disaster. Post event, all 
EMS professionals should be offered event- 
specific vaccine when applicable; an example 
was the prioritization of EMS to receive the 
H1N1 influenza vaccine during the early part 
of the H1N1 pandemic when vaccine supplies 
were insufficient. EMS should be prioritized to 
receive anti-infective therapy, prophylaxis, and 
vaccination during an infectious disease disaster 
when supplies are limited. EMS agencies should 
partner with community disaster planners to 
ensure that EMS professionals are included in 
the list of prioritized groups for pharmaceutical 
interventions. 

EMS personnel should be educated regarding 
appropriate PPE to use during an infectious 
disease disaster and ensure that adequate PPE 
supplies are available. This includes choosing the 
appropriate PPE to wear for patient care activities 
as well as when handling suspicious letters or 
packages that may contain infectious particles. 
EMS personnel should be educated regarding how 
to handle suspicious letters or packages to reduce 
their risk of exposure while maintaining chain of 
custody for the purposes of investigating potential 
bioterrorism incidents. 

PPE and other medical supplies are expected to 
be insufficient or depleted during an infectious 
disease disaster. Many hospitals are developing 
prioritization plans for allocation of PPE when 
supplies are limited. EMS agencies need to develop 
similar plans. PPE allocation should be made based 
upon the known or suspected risk of exposure 
during patient care procedures, and on the risk of 
disease for each worker. For example, aerosolizing 
procedures, such as cardiopulmonary resuscitation 
and providing nebulizer treatments, pose a high 
risk of exposure during outbreaks involving an 


68 Association for Professionals in Infection Control and Epidemiology 



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airborne or droplet spread disease. During events 
when PPE is limited, EMS agencies should consider 
prioritizing staff performing aerosolizing procedures 
to receive N95 respirators or other respiratory 
protection. EMS personnel who are at high risk 
of complications of infection, such as pregnant 
or immunocompromised workers, should either 
be prioritized to receive PPE or avoid performing 
high-risk procedures when PPE supplies are limited. 
Whenever possible, EMS agencies should develop 
a pre-event memorandum of agreement (MOA) 
or memorandum of understanding (MOU) with 
vendor(s) to ensure access to PPE and other medical 
supplies during a disaster. MOAs and MOUs will 
be most critical in preparing for biological disasters. 

Decontamination 

Decontamination may or may not be an issue 
after an infectious disease disaster, depending on 
the following factors: 

1. Type of event (bioterrorism versus emerging 
infectious disease outbreak or pandemic) 

2. Causative agent 

3. How soon the event is identified 

4. Source of concern (environment or patient). 

Most infectious disease disasters, including 
bioterrorism attacks, will likely not require patient 
decontamination. Pandemics and outbreaks of 
emerging infectious diseases will not require 
patient decontamination. In the event of a covert 
release of a biological agent, patients will not 
become symptomatic and present to healthcare 
institutions until days to weeks after the exposure. 

In this instance, they will most likely have bathed 
and changed their clothes, thus decontaminating 
themselves. Only in the event of an announced 
bioterrorism attack (within 12 to 14 hours after 
the release) will exposed individuals need to 
be decontaminated. Patient decontamination 
consists of bathing, including shampooing of hair, 
with plain soap and water and changing their 


clothing. EMS personnel are likely to be needed 
in performing patient decontamination in a 
community. It is essential that EMS professionals 
are educated about proper patient decontamination 
procedures to minimize exposure risk to 
patients and themselves. EMS personnel should 
participate in periodic exercises involving patient 
decontamination to ensure they are knowledgeable 
about these procedures and can perform them 
appropriately. 

Given existing knowledge, environmental 
decontamination is not considered necessary 
for outside sources, such as streets, cars, or the 
outside of buildings after a bioterrorism attack. 
This is because weather plays a key role in rapidly 
disseminating biological agents in outside air. 

Indoor environmental sources may require 
decontamination strategies after an infectious 
disease disaster, but the interventions vary 
according to the agent involved and the nature 
of the event. For example, more stringent 
decontamination methods are necessary for a 
bioterrorism attack using anthrax because of the 
hardy nature of spores. As the 2001 bioterrorism 
attacks illustrated, equipment or areas may require 
specialized decontamination strategies, such 
as contained buildings, ventilation systems, or 
machinery with small parts. EMS personnel may 
be the first responders on the scene of a potential 
bioterrorism attack and should be trained on the 
proper procedures for performing environmental 
decontamination, including choosing appropriate 
disinfectants and PPE to wear to protect 
themselves from exposure during decontamination 
procedures. 

Other agents—especially those that are spread via 
fomites/contaminated surfaces—require diligent 
environmental decontamination as well. Strict 
adherence to environmental decontamination 
should help reduce disease spread in these 
situations. For EMS agencies, this includes 
frequent cleaning/disinfection of the EMS vehicle 
and medical equipment. Areas within the vehicle 
that are touched most often, such as stretcher 


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rails, cabinet handles, etc., should be cleaned/ 
disinfected frequently to minimize bioburden 
in the environment. Disinfectants used for 
environmental decontamination should include 
EPA-registered germicides. All reusable patient 
care equipment should be disinfected between 
patients. 

Exercises and drills 

As part of infectious disease disaster preparedness, 
it is essential that EMS agencies participate 
in exercises and drills to test their emergency 
management plan. EMS exercises and drills should 
periodically include a biological agent scenario in 
order to assess the agency’s ability to respond to 
an infectious disease disaster. Whenever possible, 


these exercises need to be community-wide— 
involving EMS agencies, healthcare facilities/ 
agencies (including long-term care and home 
health), and community response agencies— 
to obtain a true sense of the community’s 
preparedness for this type of event. 

Cited References 

1. Carrico R, ed. APIC text of infection control and 
epidemiology. Washington, DC: Association for 
Professionals in Infection Control and Epidemiology, 
Inc., 2009; chapters 117 and 118. 

2. CDC. Strategic national stockpile (SNS). Available 
at: http://www.cdc.gov/phpr/stockpile/stockpile.htm. 
Accessed January 25, 2013. 


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Section 8: Education, Training, 
Compliance Monitoring, and Summary 


Key concepts 

• Education is a critical component of every 
infection prevention program and must be 
supported accordingly. 

• Training must be presented by a qualified 
instructor at an educational level and in 

a language that EMS system responders 
understand, and workers must have the 
opportunity to ask the trainer questions. 

• Standard/planned training and just-in- 
time training are both useful methods 
of training EMS system responders on 
infection prevention. 

• EMS system responders are more likely 
to comply with infection prevention 
strategies if they understand the rationale 
for the prevention strategies. 

• Successful programs stress the importance 
of preventing transmission of diseases to 
EMS system responders, coworkers, their 
families, and patients. 

• EMS system responders must have the 
opportunity to ask questions and be able 
to use the DICO as a resource throughout 
their career. 

• EMS system responders are constantly 
bombarded with new information and 
therefore infection prevention must be 
presented often and be reinforced. 


• Infection prevention education should 
be updated regularly and have evidence- 
based best practices, regulatory 
requirements, and compliance as its 
foundation. Eliminate fear-based training. 

• The value of a vaccination program and 
postexposure medical follow-up (counseling 
and education) cannot be understated. 

Emergency Medical Services are delivered in various 
ways to communities. Ambulance companies, 

EMS departments, fire departments, law 
enforcement agencies, and volunteer organizations 
must continue to provide quality patient care. 
Accordingly, agencies must ensure all EMS system 
responders have the knowledge and skills to safely 
respond to medical emergencies. EMS system 
responders need reinforcement of their knowledge 
of standard infection prevention precautions and 
ways to prevent occupational exposures. 

DICOs have to ensure that EMS system 
responders undergo continuing education, 
specialty training, and just-in-time training to 
keep up to date on a wide variety of information. 
Educational programs need to be concise and 
to the point. A quick drill information session 
at roll call in the morning before crews “hit the 
street” is one example of how a program could be 
reinforced and updated. See Example 8.1 for an 
example of a quick drill on MRSA. 


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Example 8.1. Sample quick drill for preventing MRSA infections 

Quick Drill 

HOT TOPIC: MRSA 



There has been a sharp increase in documented exposures to MRSA. Some firefighters’ cases of 

MRSA have been so severe they required hospitalization. 

Here are some quick facts regarding MRSA: 

• Staph is commonly found on the skin or in the nares (nasal passages) of normally healthy 
individuals. A small number of these people get MRSA. 

• Most of these skin infections are minor (e.g., pimples and boils) and can be treated without 
antibiotics (also known as antimicrobial or antibacterial). 

• Staph bacteria also can cause serious infections (e.g., surgical wound infections, bloodstream 
infections, and pneumonia). 

• Transmission occurs when EMS system responders contact purulent sites of infection or 
common items found on apparatus or in stations such as stethoscopes or other medical 
equipment, the remote control, kitchen counter, telephone, and door handles. 

• HANDS of personnel are the most common mode of transmission. 

Here are some things you can do to avoid MRSA: 

• Cover patient’s draining wounds with clean bandages and use Contact Precautions. 

• Wash hands (at least 30 seconds with liquid soap and water), especially after contact with a 
contaminated wound. 

• Launder clothing after contact with a contaminated area on the skin. Dry clothes at least 30 
minutes on high. 

• Avoid sharing items (e.g., towels, bedding, clothing, razors, or athletic equipment) that may 
become contaminated by contact with wounds or skin flora. 

• Disinfect/clean medical and sports equipment, kitchen counters, and other surfaces with an 
approved disinfectant or diluted bleach. 

• Do not bring contaminated items into station. Decontaminate kits and other items before you go 
in!! 


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Training 

Training issues have been presented throughout 
this guide. OSHA standards require new employee 
infection prevention training to include the 
agency’s Exposure Control Plan, and EMS system 
responders have to undergo this training before 
they go on medical calls. The importance of 
annual infection prevention training cannot be 
overstated. Training needs to be documented with 
the date (within a year of the previous date of 
training), content of training, trainers name with 
credentials, and names and job titles of students 
attending. EMS system responders should have 
access to infection prevention information at all 
times whether it is in hard copy form in their rig, 
at a station, or posted on the agency’s intranet site. 

Compliance monitoring 

Compliance monitoring verifies that the programs 
you implement to keep EMS system responders 
safe are working. It also ensures your agency is 
in compliance with OSHA and/or other federal 
regulatory standards. Compliance monitoring 
also drives your training program as it identifies 
any training needs or problems. Agencies need 
to establish time frames for monitoring and 
disciplinary action if policies are not followed. 
Samples of compliance monitoring forms are 
provided at the end of this section. 

EMS agencies can adopt the HHS seven 
fundamental elements for developing an effective 
compliance program 1 2 3 4 5 6 7 : 

1. Implement written policies, procedures, 
and standards of conduct 

2. Designate a compliance officer and 
compliance committee 

3. Conduct effective training and education 

4. Develop effective lines of communication 

5. Enforce standards through well-publicized 
disciplinary guidelines 

6. Conduct internal monitoring and auditing 

7. Respond promptly to detected offenses 
and develop corrective action 


Also see OSHA’s Enforcement Procedures for the 
Occupational Exposure Bloodborne Pathogens, 
which can be found at: http://www.osha.gov/ 
pis/oshaweb/owadisp.show_document?p_ 
table=DIRECTIVES&p_id=2570 

Regulations 

Federal and state regulations, including OSHA’s 
Bloodborne Pathogens standard, Title 29 of 
the Code of Federal Regulations at 29 CFR 
1910.1030, require that all healthcare workers, 
including EMS system responders, be provided 
with information and training on bloodborne 
pathogen exposure. Employers must ensure 
that their workers receive regular training that 
covers all elements of the standard. Employers 
must offer this training on initial assignment, 
at least annually thereafter, and when new or 
modified tasks or procedures affect a worker’s 
occupational exposure. Training records must be 
kept for 3 years. Agencies must be aware that the 
standard does not specifically address all of the 
communicable diseases/pathogens and risks EMS 
system responders face. Therefore, it is extremely 
important the person in charge of each agency’s 
infection prevention program—whether it be 
the EMS medical director, managers, fire chief, 
occupational health nurses, DICO, etc.—keep 
up to date with current guidelines, standards, 
initiatives, program resources, and emerging 
diseases. A quality infectious disease prevention 
education program for EMS system responders is 
imperative. 

Components infection 
prevention education 

Education related to infection prevention is 
an ongoing, constantly changing curriculum. 
Education for personnel should include the 
following components: 

• Explanation of the agency’s written 
Exposure Control Plan and location of 
plan for employee access 


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Agency’s administrative policies and 
procedures to ensure employee safety 
Explanation of the OSHA and/or local 
standards, including contents and 
compliance 

Infection prevention procedures and 
use of PPE such as gloves, goggles, and 
masks 

Recognition of tasks that may result in 
exposure to blood and OPIM 

Mandatory use of and compliance with 
appropriate safety devices and methods 

Evaluation, reporting, treatment, and 
postexposure management of significant 
exposures to blood and/or body fluids 

Documented symptoms of illnesses, 
epidemiology, portals of exposure 

Disposal of infectious and/or 
contaminated waste and sharps disposal 

Current infectious, emerging disease, and 
bioterrorism education 
Immunization updates and policies 

Education and techniques to minimize 
risks in the field 

Long-term consequences and dangers of 
noncompliance with Standard Precautions 
Work restriction guidelines (see Table 2.2) 

Documentation of agency’s incidents 
(annual numbers) and types of employee 
exposures for each incident 
Reinforcement of potential exposure risks, 
even from seemingly “healthy” patients 

Understanding risks and causes of disease 
migration to regions of no previous 
disease incidence from an increasingly 
mobile population 


Successful infection prevention education for EMS 
system responders must stress the importance of 
preventing transmission of diseases while adhering 
to local and federal standards. Documentation 
of the training should include a posteducation 
evaluation to assure all impacted personnel 
understand the importance of infection prevention 
and their safety and health risks. 

There are many resources available to EMS agencies 
to create a quality infection prevention education 
program, including this guide. Contact your local, 
county, or state health department for further 
assistance. Other possible sources of assistance include 
area EMS, Fire, Public Safety, or Law Enforcement 
agencies. Many have programs in place and will share 
them at no cost. DICOs and program administrators 
must stay current on infectious diseases and infection 
prevention issues, laws, and regulations applicable to 
their departments. Practices must be evidence-based. 

It is imperative that leadership supports and 
emphasizes the importance EMS system responder 
protection and patient safety. Patient care, devices, 
types of patients, and procedures change rapidly and 
EMS system responders have to be properly educated 
to avoid injury and exposure. The cost of training 
pales in comparison to the cost of treating one 
exposure or sharps injury. A properly implemented 
infection prevention program can save an agency 
countless dollars from OSHA fines and the fees 
associated with unnecessary emergency department 
visits. It can also prevent human and organizational 
resource issues related to an employee exposure such 
as emotional trauma, replacement costs, increased 
insurance rates, fear of exposing other EMS system 
responders, and unwanted media attention. Strong 
leadership is the driving force behind a quality 
infection prevention program. 


74 Association for Professionals in Infection Control and Epidemiology 




Guide to Infection Prevention in Emergency Medical Services 


Compliance Checklist* - General Infection Prevention 

Date: 

Practice Performed 

Policies/Task/Procedure 

Yes 

No 

Comments 

1. Written infection prevention policies and procedures are 
available and current 

□ 

□ 


2. Personal protective equipment was available, donned, 
and removed appropriately 

□ 

□ 


3. Hand hygiene supplies provided and appropriate hand 
hygiene observed 

□ 

□ 


4. Gloves were used according to policy 

□ 

□ 


5. Gloves were appropriately discarded after patient care 

□ 

□ 


6. Protective eyewear (goggles) were used according to 
policy 

□ 

□ 


7. Masks were used according to policy 

□ 

□ 


8. PPE was properly disposed of according to policy 

□ 

□ 


9. All sharps were disposed of in a puncture-resistant 
container 

□ 

□ 


10. Filled sharps containers are disposed of according to 
policy 

□ 

□ 


11. Vehicles were cleaned following medical calls 

□ 

□ 


12. Cleaning/decontamination was done using disinfectant/ 
bleach according to policy 

□ 

□ 


13. Station environmental services were cleaned/disinfected 
according to policy 

□ 

□ 


14. Decon station is appropriately marked and used 
according to policy 

□ 

□ 


15. Infection prevention policies and procedures are 
reassessed at least annually or according to state or 
federal requirements 

□ 

□ 



Employee Signature:_ 

Infection Prevention Staff/DICO. 
Comments: 


*Adapted from CDC. Infection prevention checklist for outpatient settings: minimum expectation for safe care. Avail¬ 
able at: http://www.cdc.gov/HAI/pdfs/guidelines/ambulatory-care-checklist-07-2011.pdf. Accessed January 25, 2013. 


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Infection Control Policy and Checklist* 

Review the recommendations for disinfection procedures below. Utilize this checklist to ensure daily and periodic 
cleaning and disinfection control is practiced at your station. 

General 

Yes No 


All hard environmental surfaces are cleaned and disinfected 
daily with an EPA-registered product 

□ 

□ 


Light switches, doorknobs, door push bars, elevator 
controls, handrails, and community phones are disinfected 
daily with an EPA-registered product 

□ 

□ 


All hard flooring is cleaned and disinfected daily with an 
EPA-registered product 

□ 

□ 


Mop heads and buckets utilized for restrooms, locker rooms, 
and showers should be independent from program areas and 
office space; mop heads are cleaned and disinfected weekly 

□ 

□ 


Restrooms: wall dispensers are utilized for liquid soap (no 
bar soap) 

□ 

□ 


Exercise/Weight Rooms 

Grip areas on weight bars, dumbbells, and machines are 
wiped down at the beginning of day (shift), between each 
use, end of day (shift) with an EPA-registered product or 
1:100 bleach solution; grip areas should not be taped 

□ 

□ 


Wall padding, lifting benches, stationary bike seats, and/ 
or floor mats are cleaned daily with an approved product or 
1:100 bleach solution 

□ 

□ 


Wall dispensers for hand cleaner (>70% alcohol) are placed 
at each entry/exit door; signage to indicate minimum use: 
upon entering/leaving facility 

□ 

□ 


Shower Rooms/Locker Rooms 

Showers and locker rooms (shower area, locker room floors, 
and benches) are cleaned and disinfected daily with an EPA- 
registered product and wall dispensers are utilized for liquid 
soap and are placed within or directly adjacent to showers 
(no bar soap) 

□ 

□ 


Used towels or linens utilized are only handled by employees 
with gloves 

□ 

□ 


Towels or linens laundered in EMS facilities are washed at 

160°F and dried in a clothes dryer 

□ 

□ 


Sports Equipment 

All sports equipment used during the day is cleaned and 
disinfected daily with an EPA-registered product 

□ 

□ 



*Permission to use this checklist, from Ed Neid, Deputy Chief, Tucson Fire Dept. 

1 U.S. Department of Health and Human Services, Office of the Inspector General. Publication of OIG compliance 
program guidance for clinical laboratories. Federal Register 1998;63(163). 


76 Association for Professionals in Infection Control and Epidemiology 


































Guide to Infection Prevention in Emergency Medical Services 


References and Resources 

CDC. General Resources on Bloodborne Pathogens, 
Engineering Controls and Personal Protective 
Equipment. Available at: http://www.cdc.gov/niosh/ 
topics/bbp/universal.html Accessed December 13, 
2012. 

NIOSH Alert, Preventing Needlestick Injuries in 
Healthcare Settings. Available at: http://www.cdc.gov/ 
niosh/docs/2000-108/pdfs/2000-108.pdf Accessed 
December 13, 2012. 


International Association of Firefighters, IAFF, 
Occupational Disease, http://www.iaff.org/hs/index. 
htm Accessed December 13, 2012. 

The Northwest AIDS Education and Training Center. 
Postexposure Prophylaxis for Occupational Bloodborne 
Exposures. Available at: http://depts.washington.edu/ 
nwaetc/resources/PEPManual.pdf. Accessed December 
13, 2012. 


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APPENDIX A: Sample Ambulance 
Cleaning Procedures 

Salt River Fire Department 

Ambulance Cleaning Procedures 

Used with permission courtesy of Salt River Fire Department, Scottsdale, Arizona. 

Purpose 

To ensure that ambulances that are being used for patient transport are properly cleaned after every 
transport in a standardized manner. To provide for the most sterile environment for Fire Department 
personnel and the patients they serve. This cleaning and disinfecting procedure is required and essential 
to ensure employee safety as well as that of the patients that are treated and transported daily. 

I. Cleaning the vehicle and EMS equipment between calls and at the end of the shift. 

(This should be monitored by the station Captain, whenever possible.) 

A. Personal Protective Equipment (PPE) is used: 

1. Isolation gown (if necessary) 

2. Mask (if necessary) 

3. Eye protection (MANDATORY) 

4. Booties (if necessary) 

5. Gloves (MANDATORY) 

B. Cleaning and disinfecting of equipment should be performed at the receiving medical facility 
as much as possible. Some facilities are equipped with a designated area to remove heavily 
contaminated equipment. Large items can be taken to this area and the majority of the 
contaminates hosed off into a containment area. Complete PPE should be worn in this area. 
The fewer contaminated items on board, the lesser the risk to exposure. Some equipment items 
may take extensive cleaning and decontamination efforts. These items must be red-bagged and 
transported back to quarters for immediate cleaning. 

C. To clean, deodorize, and disinfect hold the cleaning agent mixture dispenser 10 inches from the 
surface and atomize with quick short strokes, spraying evenly on contaminated or potentially 
contaminated areas of the equipment and affected interior patient compartment of the ambulance 
or other affected portions of the vehicle until wet. Wait 30 seconds and wipe dry with a paper 
towel. To kill staph, strep, and other common types of virus and bacteria strains, repeat as above, 
wait 10 minutes, and wipe dry. Blood and other body fluids must be thoroughly cleaned from 
surfaces and objects before application of the disinfectant. 

D. Steps in cleaning after each transport: 

1. Remove gurney. 


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2. All visible debris and soil contaminants are wiped off with towels. 

3. Cleaning agent mixture is sprayed liberally on the interior of the transport compartment of 
the vehicle. 

4 Cleaning agent mixture is sprayed liberally on the gurney mattress, the gurney frame, 
including wheels. 

5. All surfaces are inspected to ensure that no visible signs of debris, soil, or contaminants are 
present; if such signs still exist, then repeat the cleaning process. 

6. Towels are disposed of appropriately for washing. Paper towels must be placed in a red or 
properly marked biohazard bag or container if blood-soaked; otherwise, they may be treated 
as normal trash per Scottsdale Health Care SOGs. 

7. Gloves must be placed in a red or properly marked biohazard bag or container if blood- 
soaked; otherwise, they may be treated as normal trash per Scottsdale Health Care SOGs. 

II. Special Equipment Cleaning Instructions 

A. Patient restraint straps (spine board, gurney); remove immediately when contaminated with 
blood or body fluids or body substances/secretions and place in a red or appropriately marked 
biohazard bag. 

1. Straps are washed upon return to the station in an appropriate detergent according to 
manufactures instruction and recommendations. 

2. Air or machine dry as recommended. 

B. Equipment bags made of Cordura nylon; remove from service immediately when contaminated 
with blood, body fluids, or body substances/secretions and place in a red or appropriately marked 
biohazard bag. 

1. The bags will be washed upon return to the station in appropriate detergent according to 
manufacturer instructions and recommendations. 

2. Air or machine dry as recommended. 

C. MAST/PASG: Before washing, all gauges are removed, using the quick-disconnect 
tubing and closing all valves. Washing is done by hand in soapy water. DO NOT DRY 
CLEAN, BLEACH, STEAM CLEAN, OR USE HARSH CHEMICALS. FOLLOW 
MANUFACTURERS INSTRUCTIONS. 

D Laryngoscope blades and Magill forceps, portable suction units (and any other nondisposable 
instruments that touch mucous membrane): equipment is cleaned with the cleaning agent 
mixture ensuring complete coverage with the agent mixture and then rinsing. Ensure that all 
needles and contaminated scalpels are placed in a sharps container 

E. The radio equipment should be decontaminated by spraying cleaning agent on a towel and 
wiping down the portable radio and microphones/mobile radio. 

F. Turnouts that have been contaminated should be removed from the individual, bagged in a red 
bag or appropriate biohazard container, and taken to the station. The turnouts should be first 
hosed off and brushed using liquid detergent that does not have any chlorine products. Once hosed 
off, the coat and pants should be separated from the liner (if possible) and placed in a washing 
machine with soap and hot water. The turnouts and liners should be air-dried. The washing 
machine should be cleaned using a 10% mixture of bleach and run through a complete cycle. 


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APPENDIX B: Sample Exposure Control Plan 


North Dakota Ambulance Service 

Exposure Control 

DISCLAIMER 

The protocols developed by the North Dakota Department of Health are meant to be used as general guidance for 
developing protocols for individual emergency medical services agencies. These sample protocols are not meant to be 
medical or legal advice; nor do they establish standards of care. Each emergency medical services agency must tailor 
protocols based on their specific needs or capabilities. Local medical directors must be consulted with and approve 
any protocol(s) prior to becoming operational in an emergency medical services agency. 

Ambulances will be following the Occupational Safety and Health Administration (OSHA) standards to limit 
occupational exposure to blood and other potentially infectious materials since any exposure could result in 
transmissions of bloodborne pathogens which could lead to disease or death. Each member of the staff will 
receive training at least annually about the information contained in this plan and will be expected to follow 
the procedures outlined and use the equipment provided. Any questions should be referred to management. 

1. POTENTIAL INFECTIOUS PLACES AND/OR MATERIALS 

a. Semen 

b. Vaginal secretions 

c. Cerebrospinal fluid 

d. Synovial fluid 

e. Pleural fluid 

f. Pericardial fluid 

g. Peritoneal fluid 

h. Amniotic fluid 

i. Saliva 

j. Any body fluid visually contaminated with blood and all body fluids 
is difficult or impossible to differentiate between body fluids 

k. Any unfixed tissue or organs other than intact from a human (living 
cells or tissue cultures 

**A11 personnel working on ambulance crews and first responders are at risk for exposure to blood and 
bodily fluids. 

2. Possible areas in the workplace that could be contaminated with bloodborne pathogens: 

a. Every call could be potential for contamination, therefore it is mandatory that all safety 
precautions be taken when doing patient care (universal blood precautions). 

b. Cleaning inside patient care area of ambulance, safety precautions must be followed 
(universal blood precautions). 

c. When cleaning any patient care equipment, safety precautions must be followed (universal 
blood precautions). 


in situations where it 
or dead) and HIV 


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Guide to Infection Prevention in Emergency Medical Services 


3. Personal Protective Equipment that will be provided: 

a Nonsterile latex-free gloves. 

b. Gowns 

c. Goggles 

d. Masks 

e. Sharps disposal system 

f. Fluid absorbent, dust pan, and whisk broom 

g. Small resealable plastic bags 

h. Hand cleaner 

4. Universal Precautions 

a. Nonsterile gloves will be used when handling body fluids, secretions, and excretions as well as 
articles contaminated with them. Gloves shall be worn when in contact with mucous membranes 
and nonintact skin. 

b. Hands shall be washed immediately if they are in contact with blood or body fluids and 
after completion of each call. Hand sanitizer is a waterless product located in all rigs for 
times when soap and water washing are not available. Wash your hands with soap and 
water as soon as you get the opportunity after using the approved hand sanitizer. 

c. Gown if soiling is anticipated with blood and/or body fluids, secretions, or excretions. 

d. Goggles, if splashing of blood and/or body fluids is anticipated. 

e. Mask, if sustained contact with patient who is coughing extensively, for intubated patients 
being suctioned, or if splashing of blood and/or body fluids is anticipated. 

f. Dispose of sharps in receptacles. Only recap needles by using one hand to hold the base of 
the needle as you slide it back into the protective cap. Do not stick your hand or fingers in a 
sharps container or place garbage in a sharps container. 

g. Do not eat, drink, smoke, apply makeup or lip balm, or adjust contact lenses in the patient 
compartment of the ambulance. 

5. HBV immunizations 

a. The service will provide hepatitis B immunizations to all team members. 

b. The service will also provide annual education on precautionary measures, epidemiology, 
and modes of transmission and prevention of HIV/HBV. 

c. Immunizations should be started within ten (10) working days of employment, unless the team 
member refuses or has medical documentation that states that the team member does not need 
the immunization. 

6. Types of significant exposure: 

a. Contact with your nonintact skin (i.e., rash, lesion, open/healing wound, etc.). 

b. Contact with your eyes. 

c. Contact with your mouth, nose, or mucous membranes. 

d. Puncture or penetration of your skin by any contaminated object. 

7. Nonsignificant exposures: 

a. Contact with intact skin. 

b. Contact with clothing that does not soak through. 

8. Steps to follow when exposed to body secretions: 

a. Fill out an incident report to include: (a) name of patient; (b) any precautions that were 
taken at time of injury. 

b. Fill out an exposure form at the hospital. 


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c. Wait for report that will tell you if you need to be tested. 

d. If testing is needed, contact your supervisor. 

e. Copies of all reports must be kept on file at the facility. (These files will be kept confidential.) 

f. If you test positive for HIV or HBV you can go to the hospital for counseling. All testing 
should be done as soon as possible or within 24 hours of the exposure. 

g. Any time contact is made with a patient with a communicable disease, notify the 
operations supervisor so he/she can contact other responders. 

9. Instructions for Exposed Materials: 

a. Contaminated disposable items will be placed in a red garbage bag in the ambulance or at 
the hospital. 

b. Reusable equipment will be disinfected. Laryngoscope blades and stylettes shall be cleaned 
with soap and water, placed in approved cleaner for ten (10) minutes, and washed with soap 
and water again. 

c. Soiled linen shall be placed in red bags. Normal bed linen can go to the cleaners. 

d. Contaminated clothing shall be placed in red bags and taken to the cleaners. Do not take 
visibly contaminated clothing home to be washed. 

10. Ambulance Decontamination 

a. In the event the ambulance is used to transport a patient with a known communicable 
disease, or the ambulance becomes contaminated with blood or bodily fluid, the unit will 
be taken out of service after the transport to be cleaned. 

b. Materials to use for cleaning: 

i. Spray cleaner (e.g., Hepacide® and BH38) 

ii. Sani Wipes® 

iii. Towels 

iv. Gloves 

v. Chlorasorb 

vi. Broom and dustpan 

c. Procedures for cleaning: 

i. Spray all surfaces then wipe. 

ii. Remove all linen and place in the red garbage bags. 

iii. Use Chlorasorb or other fluid absorbent if needed to clean up large or small amounts of 
blood, vomit, urine, etc. 

iv. After each call the ambulance shall be inspected for bodily fluids and general 
contaminates. If you suspect contamination, Hepacide or other cleaner shall be used to 
disinfect the soiled areas. BH38 may be used for general cleaning. 

d. High Level Decontamination: Hepacide 

i. Should be done once per month, and will be total ambulance decontamination. 

ii. Any time bodily fluids cause a biohazard in the unit, the area or equipment will be 
decontaminated. 

c. Low Level Cleaning: BH-38 

i. General cleaning of the unit of soil or as needed. 


Medical Director’s Signature Date 


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APPENDIX C 


Definition of Terms 

OSH A - Occupational Safety and Health Administration 

U.S. Department of Labor 

• Bloodborne pathogens. - 1910.1030 

• Regulations (Standards - 29 CFR) - Table of Contents 

• Part Number: 1910 

• Part Title: Occupational Safety and Health Standards 

• Subpart: Z 

• Subpart Title: Toxic and Hazardous Substances 

• Standard Number: 1910.1030 

• Title: Bloodborne pathogens. 

• Appendix: A 

1910.1030(a) Scope and Application. This section applies to all occupational exposure to blood or other 
potentially infectious materials as defined by paragraph (b) of this section. 

1910.1030(b) Definitions. For purposes of this section, the following shall apply: 

Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, or 
designated representative. 

Blood means human blood, human blood components, and products made from human blood. 

Bloodborne Pathogens means pathogenic microorganisms that are present in human blood and can 
cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and 
human immunodeficiency virus (HIV). 

Clinical Laboratory means a workplace where diagnostic or other screening procedures are performed 
on blood or other potentially infectious materials. 

Contaminated means the presence or the reasonably anticipated presence of blood or other potentially 
infectious materials on an item or surface. 

Contaminated Laundry means laundry which has been soiled with blood or other potentially infectious 
materials or may contain sharps. 

Contaminated Sharps means any contaminated object that can penetrate the skin including, but not 
limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. 


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Decontamination means the use of physical or chemical means to remove, inactivate, or destroy 
bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting 
infectious particles and the surface or item is rendered safe for handling, use, or disposal. 

Director means the Director of the National Institute for Occupational Safety and Health, U.S. 
Department of Health and Human Services, or designated representative. 

Engineering Controls means controls (e.g., sharps disposal containers, self-sheathing needles, safer 
medical devices, such as sharps with engineered sharps injury protections and needleless systems) that 
isolate or remove the bloodborne pathogens hazard from the workplace. 

Exposure Incident means a specific eye, mouth, other mucous membrane, nonintact skin, or parenteral 
contact with blood or other potentially infectious materials that results from the performance of an 
employee’s duties. 

Fomites is an inanimate object or substance, such as clothing, furniture, or soap, that is capable of 
transmitting infectious organisms from one individual to another. 

Hand Washing Facilities means a facility providing an adequate supply of running potable water, soap, 
and single-use towels or hot air drying machines. 

HBV means hepatitis B virus. 

HIV means human immunodeficiency virus. 

Licensed Healthcare Professional is a person whose legally permitted scope of practice allows him 
or her to independently perform the activities required by paragraph (f) Hepatitis B Vaccination and 
Postexposure Evaluation and Follow-up. 

Needleless systems means a device that does not use needles for: (1) the collection of bodily fluids or 
withdrawal of body fluids after initial venous or arterial access is established; (2) the administration of 
medication or fluids; or (3) any other procedure involving the potential for occupational exposure to 
bloodborne pathogens due to percutaneous injuries from contaminated sharps. 

Occupational Exposure means reasonably anticipated skin, eye, mucous membrane, or 
parenteral contact with blood or other potentially infectious materials that may result from the 
performance of an employees duties. 

Other Potentially Infectious Materials means (1) the following human body fluids: semen, vaginal 
secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic 
fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body 
fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) any unfixed 
tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or 
tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and 
blood, organs, or other tissues from experimental animals infected with HIV or HBV. 

Parenteral means piercing mucous membranes or the skin barrier through such events as needlesticks, 
human bites, cuts, and abrasions. 


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Guide to Infection Prevention in Emergency Medical Services 


Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection 
against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) not intended to function 
as protection against a hazard are not considered to be personal protective equipment. 

Production Facility means a facility engaged in industrial-scale, large-volume, or high 
concentration production of HIV or HBV. 

Regulated Waste means liquid or semiliquid blood or other potentially infectious materials; 
contaminated items that would release blood or other potentially infectious materials in a liquid or 
semiliquid state if compressed; items that are caked with dried blood or other potentially infectious 
materials and are capable of releasing these materials during handling; contaminated sharps; and 
pathological and microbiological wastes containing blood or other potentially infectious materials. 

Research Laboratory means a laboratory producing or using research laboratory-scale amounts of HIV 
or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume 
found in production facilities. 

Sharps with engineered sharps injury protections means a non-needle sharp or a needle device used for 
withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a 
built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. 

Source Individual means any individual, living or dead, whose blood or other potentially infectious 
materials may be a source of occupational exposure to the employee. Examples include, but are not 
limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma 
victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human 
remains; and individuals who donate or sell blood or blood components. 

Sterilize means the use of a physical or chemical procedure to destroy all microbial life including highly 
resistant bacterial endospores. 

**Universal Precautions is an approach to infection control. According to the concept of Universal 
Precautions, all human blood and certain human body fluids are treated as if known to be infectious for 
HIV, HBV, and other bloodborne pathogens. 

Vector is an organism, such as a mosquito or tick that carries disease-causing microorganisms from one 
host to another. 

Work Practice Controls means controls that reduce the likelihood of exposure by altering the 
manner in which a task is performed (e.g., prohibiting recapping of needles by technique). 

^Although OSHA still uses the term Universal Precautions and focuses mainly on blood exposures, 
many EMS systems use the more common term Standard Precautions. 

Standard Precautions are based on the principle that all blood, body fluid secretions, excretions 
except sweat, nonintact skin, and mucous membranes may contain infectious diseases. Implementation 
of Standard Precautions constitutes the primary strategy for the prevention of healthcare-associated 
transmission of infectious agents among patients and healthcare personnel. 


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APPENDIX D 


Acronyms and Abbreviations 

ARO - Antibiotic-resistant organisms 

CDC - The Centers for Disease Control and Prevention 

DICO - Designated Infection Control Officers 

ECP - Exposure Control Plan 

EMT - Emergency medical technicians 

EMS - Emergency Medical Services 

EPA — Environmental Protection Agency 

FOG - Field Operations Guides 

HBV - Hepatitis B virus 

HCV - Hepatitis C virus 

HHS - U.S. Department of Health and Human Services 

HIPAA - Health Insurance Portability and Accountability Act 

HIV - Human immunodeficiency virus 

IP - Infection preventionist 

MDRO- Multidrug -resistant organism 

MRSA — Methicillin -resistant Staphylococcus aureus 

MSDS - Material Safety Data Sheets 

NIOSH - The National Institute for Occupational Safety and Health 

OPIM - Other potentially infectious materials 

PPE - Personal protective equipment 

SARS - Severe acute respiratory syndrome 

SNS - Strategic National Stockpile 


86 Association for Professionals in Infection Control and Epidemiology 



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8. Legal Issues | Overview of Infection Prevention Programs | Table of Contents | APIC 


APIC 

XrVT OF INFECTION CONTROL 
i txV I AND EPIDEMIOLOGY 


Legal Issues 


Author(s): Brigid Sheridan, RN, JD 

Associate General Council 

University Health System 
San Antonio, TX 

Published: October 3, 2014 


Abstract 

Lawsuits against healthcare providers typically involve both civil actions against an organization and 
professional malpractice suits against physicians and other healthcare practitioners that work at the 
organization. The fear of litigation is the primary reason practitioners pay attention to standards, state 
rules, and federal laws that govern their practice. The specialty of infection prevention brings to light 
many issues that have both legal and ethical implications that should be considered in any decision¬ 
making process. 

Key Concepts 

• The legal nature of infection prevention issues. 

• The laws and legal cases that set the precedent for determining the outcome of a legal issue. 

• The ethical situations that arise in healthcare and involve infection preventionists. 

• The importance of effective infection prevention and control and risk management programs. 

• Analyze the changing legal climate and the activities that infection preventionists must perform to 
reduce the likelihood of a legal matter. 

• Organizational leaders' responsibility and role in reducing the risk and liability for themselves and for 
the organization. 

Background 

The Centers for Disease Control and Prevention (CDC) estimates that 1 of every 10 to 20 patients 
hospitalized in the United States develops a healthcare-associated infection (HAI). Healthcare institutions 


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have for some time focused infection prevention efforts on monitoring patient clinical outcomes and 
finding ways to prevent HAIs. Recently, healthcare organizations, professional associations, government 
and accrediting agencies, legislators, regulators, payers, and consumer advocacy groups made HAIs a 
national priority. Evidence-based practice recommendations for detecting and preventing HAIs contain 
ways to assist acute care hospitals with implementing and prioritizing their HAI prevention efforts. 
Hospitals routinely focus their work on central line-associated bloodstream infections (CLABSIs), 
ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTIs), and 
surgical site infections (SSIs). In addition, two organism-specific HAI categories, methicillin-resistant 
Staphylococcus aureus (MRSA) infection and Clostridium difficile infection (CDI), command prevention 
efforts because of the increasing incidence, morbidity, and legal actions associated with acquisition of 
these organisms in the acute care setting and in the community at large. 

Because of the shift from control to prevention, the Association for Professionals in Infection Control and 
Epidemiology (APIC) announced a scope change from infection control practitioners to infection 
preventionists, who take responsibility to implement policies and procedures that reduce or prevent 
HAIs. The change in title to an infection preventionist (IP) reflects the broad array of responsibilities that 
these professionals have, such as ensuring that the organization and its employees follow established 
standards of care to protect employees, patients, and patients' family members from exposure to 
infection and to maintain an environment of safety and protection from injury. In order to do so, IPs 
must ensure: 

1. Accurate and complete documentation reflects the care provided. 

2. Organizations implement and monitor compliance with National Patient Safety Goals. 

3. Organizations maintain patient and employee confidentiality. 

4. Organizations develop clear policies and systems to control and prevent the spread of infection 
from healthcare personnel to patient and vice versa and to the community. 

5. The infection prevention department works in concert with the risk management and quality 
assurance departments. 

The IP becomes integral and often leads the efforts in emergency management, bioterrorism, 
construction and renovation projects, and planning for pandemic outbreaks. The emergence of 
community infections and chronic infections also presents unique challenges for the IP who requires 
continued training to meet inpatient and community needs. 

When an issue of potential liability arises, organizations should consult with legal counsel to assure an 
accurate account of the findings in the matter. Resolution of legal issues usually depends on whether 
state or federal law applies to the situation, and in the absence of written statutes, whether a preceding 
case decision has set the legal precedent. 

Basic Principles 

In general, rules create laws that govern the behavior of individuals in this country. These rules may 
surface in the form of federal and state constitutions, statutes, administrative laws, written court 
decisions, and case law. When written statutes do not apply in a particular case, or when case 
precedent does not exist, the court decides the law. Common law is the law created when there is no 
statute governing a particular situation at hand. 

A constitutional right, a statute, or common law creates a legal cause of action. A cause of action has 
several elements. Attorneys must prove each element before the plaintiff (the person on whose behalf 


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the suit is filed) can establish legal liability on the part of the defendant (the person being sued). 

In general, for a person to bring a cause of action against another, the following elements must exist: 

• The plaintiff must have an interest that is protected by law. 

• The plaintiff must show the defendant had a legal duty to act. 

• The plaintiff must prove the defendant breached the duty to act. 

• The plaintiff must show injury or damage to the protected interest. 

• The plaintiff must prove that the defendant's breach of duty caused the injury. 

Initially, the burden of proof rests with the plaintiff. The plaintiff's case must establish a burden of proof 
by a preponderance of the evidence. If the plaintiff succeeds in establishing proof, the burden of proof 
shifts to the defendant. If the plaintiff establishes liability, the plaintiff must then prove damages. In some 
cases, the court may decide there are no material fact issues and that the required elements of the 
cause of action do not exist or that a legal defense exists. In these cases, the court grants summary 
judgment in favor of the prevailing party without a trial. 

Medical malpractice is legally defined as professional negligence by act or omission by a healthcare 
provider in which the treatment provided falls below the accepted standard of practice in the medical 
community and causes harm to the patient. Physicians generally obtain professional liability insurancesto 
offset the risk and costs of lawsuits based on medical malpractice. Other healthcare providers can also 
procure their own professional liability insurance but most do not because of the high cost of the 
insurance coverage and rely solely upon the general liability coverage provided by their employer. The 
medical malpractice cases filed in the legal system generally seek large amounts of monetary 
compensation, and no matter how small or large the claim, the cost of defending the claim impacts 
healthcare professionals and the healthcare organization involved. Large monetary awards in medical 
malpractice cases that proceed to a jury trial receive notoriety that in turn encourage the filing of 
medical malpractice claims by others, thus perpetuating the cycle of litigation that impacts the cost of 
delivery of healthcare and threatens the overall accessibility, affordability, and quality of healthcare in 
this country. 

A person acts negligently if he or she departs from the conduct expected of a reasonably prudent 
person acting under similar circumstances. Departure from reasonable conduct may take the form of an 
omission or commission of an act. Omission of an act includes: 

• Failing to administer medications. 

• Failing to order diagnostic tests. 

• Failing to follow up on abnormal test results. 

Commission may include: 

• Administering the wrong medication to a patient. 

• Administering medication to the wrong patient. 

• Performing a surgical procedure without patient or family consent. 

For a plaintiff to recover damages resulting from a negligent act, the plaintiff must address the following 
four elements. 

1. Duty: an obligation to conform to a recognized standard of care. 


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2. Breach of duty: a deviation from the recognized standard of care. 

3. Causation: an act or conduct departing from the recognized standard of care that caused injury. 

4. Injury: the result of the deviation from the recognized standard of care 

To illustrate negligence, consider an example of a patient who acquires an infection during his or her 
hospital stay. The patient must establish: 

1. He or she contracted an infection in the hospital. 

2. The hospital, through an act of negligence, breached its duty to the patient and did not follow a 
policy or procedure to prevent the infection. 

3. The hospital's negligence caused the infection. 

4. The patient's condition worsened because of the infection. 

The test for negligence in this example rests on whether the hospital care or lack of care caused the 
infection and whether the hospital and the personnel working with the patient acted in a reasonable and 
prudent manner to recognize, report, and try to control the infection. 

CAUSATION, DAMAGES, AND LIABILITY 

To prevail in a negligence action, the patient must prove that the hospital's failure to exercise a required 
standard of care directly caused the plaintiff's injury. The plaintiff proves the act or omission of the act 
resulted in the immediate damage without intervention of another party. This is referred to as the 
proximate cause. If the patient's attorney can establish that their plaintiff client experienced injury due to 
an infection resulting from the hospital or staff negligence, the hospital or its staff may be liable. 

Liability is not established on mere proof that a patient developed an infection. Because HAIs are 
common, unpredictable, and sometimes difficult to prevent, courts have recognized that such infections 
may occur despite reasonable care. For example, in Simmons v. United States, a patient developed an 
abscess around an intravenous needle site. The court stated that proper prophylactic care (such as 
using a sterile needle and frequent dressing examination and change) does not eliminate the possibility 
of developing an infection. Hospital employees, therefore, must be alert to infections and immediately 
report suspected infections to the physician. 

A provider may not be liable for infection sustained by a patient who is more susceptible to infection 
than the average patient. For example, in the 1994 case Lawlor-Covell v. Wack, M.D., a leukemia 
patient with a decreased white blood cell count died of an infection. The patient's family alleged that the 
patient contracted the infection due to the negligence of a hospital worker who did not adhere to the 
hospital's infection prevention policies. However, the jury found that the defendant did not act negligently 
and rendered its verdict on behalf of the hospital. Because of difficulty establishing that a particular act 
or omission specifically resulted in infection, patients are rarely awarded damages for hospital- 
associated infections. However, as methods of detecting microorganisms improve, the ability to trace the 
specific sources of infections, thereby proving proximate causation, also improves. 

PROVIDER DEFENSES TO NEGLIGENCE 

Despite a patient's ability to establish all required elements for medical negligence, the healthcare 
provider can raise affirmative defenses that, if proven, excuse the healthcare provider from liability. An 
affirmative defense is a response to a plaintiff's claim that attacks the plaintiff's legal right to bring an 
action, as opposed to attacking the truth of the claim. Examples of affirmative defenses include: (1) the 
statute of limitations, (2) assumption of risk, (3) contributory negligence, (4) release/waiver, and (5) any 
other matter that constitutes avoidance. These legal approaches can eliminate or reduce liability even if 


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the plaintiff can establish all the necessary elements of a cause of action. The statute of limitations 
prevents the plaintiff from initiating a lawsuit after a statutorily defined period of time has elapsed. The 
assumption-of-risk defense prevents a recovery of damages when the plaintiff perceives a risk and still 
voluntarily exposes him- or herself to the risk. Contributory negligence arises when the plaintiff fails to 
exercise ordinary care and self-protection, thereby contributing to the injury. A release or waiver 
executed by a patient may relieve the defendant of liability for the results of subsequent treatment. 

Other defenses that may excuse a defendant from liability include Good Samaritan (charitable immunity) 
statutes, workers' compensation, and government immunity. 

THEORIES OF LIABILITY 

Liability can be imposed on any healthcare provider, including hospitals, physicians, and nurses. 
According to the CDC, an estimated 2 million cases of nosocomial infections (now known as HAIs) occur 
annually. Hospital liability for negligence relating to an HAI arises from two different theories. The first 
theory is that negligence arises from the behavior of one or more employees or agents. According to 
the California 4th Appellate Court case Sababin v. Superior Court (Covina Rehabilitation Center) (2006), 
the appellate judge concluded that the trial issues were whether Covina's employees acted recklessly or 
with malicious neglect. The court found that employees failed to follow the patient's care plan for 
maintaining the health and integrity of the patient's skin. The appellate court remanded the case to the 
trial court asking that the court consider Covina's argument that it was not liable for its employees' 
conduct. 

The second theory holds that a hospital corporation itself may be negligent if the hospital corporation 
fails to perform a legally recognized duty to protect the patient from harm. If a staff physician, resident, 
nurse, or other hospital employee is negligent with respect to a patient, negligence may be imputed to 
the hospital, and the patient may have a cause of action against both the employee and the hospital- 
employer. Even if an employer is found to be liable under the principle of agency, the employee who 
actually committed the act can also be held personally liable for his or her actions or failure to take 
action. A patient may sue any one party separately or all of them collectively. 

DUTY TO PROVIDE CARE 

To establish a case of negligence, the plaintiff must prove that he or she had a patient/provider 
relationship with the defendant, and that the defendant had a duty or obligation of performance to 
provide care. Duty may arise from a relationship that exists between the doctor and the patient or the 
nursing staff and the patient to protect the patient from harm or injury. In the healthcare context, a duty 
translates to a standard of care. Once patients place themselves under a healthcare practitioner's care, 
the practitioner has a duty to provide the patient with reasonable care. A duty of care corresponds with 
the responsibility not only to provide care or treatment but to do so in an acceptable manner. 

To prove negligence, the patient must establish that the hospital failed to meet a standard of care. The 
standard of care depends on the circumstances of the particular case and often attorneys disagree in 
the determination of the applicable standard of reasonable care in a specific situation. Further, attorneys 
must determine whether the physician, nurse, other staff members, or the hospital breached the 
standard of care. 

Whether a patient outcome meets the definition of negligence depends on whether care practices 
conform to the standards of other providers in the same locality. Under this customary practice standard 
rule of the local community, or locality rule, the legal community measures the provider's performance 
against the level of care delivered by reasonably competent persons, or institutions, of equivalent skill in 
the same or similar geographic community. Thus, the legal society concentrates on collecting evidence 


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to determine whether or not the provider did something uncustomary or failed to do something that was 
customary practice. 

Today, most states have substituted the locality rule in favor of a more national standard of care. The 
national approach assumes evidence-based practice to result in one prevailing level of care. Experts 
may frequently disagree about what constitutes appropriate safe care or best practice in specific 
situations. The disagreement, diversity, or lack of standardization causes a variety of approaches that 
define the standard of care for a given clinical situation. Thanks to efforts from national leaders such as 
the National Quality Forum (NQF), Agency for Healthcare Research and Quality (AHRQ), Institute of 
Medicine (IOM), and The Joint Commission (TJC), "best practice" standards have emerged for 
healthcare organizations. Organizations that institute national standards can compare their results with 
other similar organizations and with national benchmarks. 

When a person alleges that a healthcare provider fails to meet a standard of care, the person must first 
establish the standard and then prove the organization or individual breached the standard. This proof 
normally comes from expert testimony. Alternatives to expert testimony include use of medical texts, 
journals, state and federal laws, regulations, and guidelines, protocols, and practice parameters. 

PRACTICE PARAMETERS 

Hospitals and other healthcare institutions have the arduous task of caring for patients with complex 
medical conditions and comorbidities such as chronic diseases and antibiotic-resistant infections. The 
American Medical Association (AMA) and TJC support the development and implementation of practice 
parameters. Practice parameters, or practice protocols, are medical guidelines that encompass a broad 
range of strategies designed to assist practitioners in the clinical decision-making process. More 
specifically, they are standardized specifications for care developed through a formal process that 
incorporates the best scientific evidence of effectiveness with expert opinion. Medical professionals in 
specific areas set these guidelines in order to advise colleagues of the recommended standard of care 
to use in a given situation. For example, the goal of practice parameters established by the Agency for 
Health Care Policy and Research (AHCPR), a federal agency empowered to establish practice 
parameters, is to encourage physicians and other healthcare providers to change their practice behavior 
by adopting guidelines, thus improving patient care, patient outcomes, and quality of life. 

Practice parameters assist healthcare facilities to meet national quality indicators. In 1998, the Centers 
for Medicare & Medicaid Services (CMS) developed 24 quality indicators to improve care delivered in 
skilled nursing facilities and nursing homes. Quality indicators include reducing the incidence of falls and 
infections, reducing the rates of pressure ulcers, and eliminating incidents of dehydration. Practice 
parameters, also called protocols, clinical pathways, or care maps, serve as tools that guide a 
practitioner in the care of a particular condition. Practice parameters often include strategies to meet a 
specific quality indicator. Practice parameters allow for variances in the patient's condition and take into 
account the comorbidities of a patient's condition. 

Practice parameters are not absolute rules of conduct. Because compliance is voluntary, most practice 
parameters include incentives for physicians, healthcare institutions, and healthcare workers. Incentives 
may include full reimbursement for care, reduced length of stay in a hospital, national recognition from 
accreditation associations, higher patient satisfaction, lower risk management premiums, and fewer 
survey enforcement activities from state and federal regulators. Such incentives help shape the conduct 
of physicians, institutions, and other healthcare personnel, thereby improving patient care, patient 
outcomes, and quality of life. The diversity of interests participating in the practice parameters 
movement contributes to the standard of practice momentum. Active participants, such as state 


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governments, private healthcare researchers, third-party payers and health benefit plan sponsors, 
medical specialty societies, and voluntary health organizations, drive the standardization concept that 
improves the quality, safety, and affordability of medical care. 

STANDARD OF CARE IN HEALTHCARE-ASSOCIATED INFECTION CASES 

Although hospitals have a duty to protect patients from injury due to infections, courts never maintain 
that organizations guarantee that patients will not acquire an infection while in the institution. However, 
organizations must realize that the potential of liability exists if a patient's infection results from 
negligence of its physicians or employees. 

To determine a standard of care, organizations must monitor patient outcomes. At a minimum, 
monitoring includes conducting quality assurance activities such as: performing infection surveillance; 
reviewing and revising infection prevention policies and procedures; providing in-service training 
sessions for staff about appropriate infection prevention practices; and adhering to the National Patient 
Safety Goals (NPSGs). Two NPSGs that relate to infection prevention include compliance with the hand 
hygiene guidelines and managing identified cases of unexpected death or major permanent loss of 
function associated with HAIs as a sentinel event. 

If a patient establishes that he or she acquired an infection at a hospital, the hospital may have to 
prove infection prevention policies and practices were in place and that the physician and staff took 
immediate and appropriate interventions to treat and minimize the patient's infection. To ensure that the 
hospital meets its standard of care, the hospital should continuously evaluate how staff use aseptic 
technique and follow infection prevention procedures. Organizations should monitor with consistency 
through direct observation of staff performance to validate proper compliance. The organization should 
make sure that all members of the healthcare team follow state and federal infection prevention 
regulations, accreditation standards, and practices and procedures. In addition to staff compliance with 
infection prevention practices, organizations should establish clear, useful internal practice manuals that 
are readily available to all staff members. 

Accreditation requirements, federal and state laws, and regulations provide an organization with 
established standards of care. In some instances, the standard of care serves as a substitute for expert 
testimony. In most states, organizations are subject to government rules regulating the practice of 
infection prevention. Program requirements vary considerably from state to state; thus, healthcare 
leaders and legal counsel should consult their own state's regulations. Some states allow considerable 
latitude in procedures, providing little guidance. Other states, such as Illinois, set forth explicit 
requirements for infection prevention procedures, including requirements for the sterilization of 
equipment, instruments, utensils, water, and supplies. Some state laws and regulations even specify the 
particular methods of sterilization to be used. Courts have sometimes ruled that these regulations 
establish guidelines for minimum standards of hospital care. However, mere compliance with minimum 
statutory or regulatory standards and licensure provisions may not preclude an organization from 
liability. Courts may hold organizations to a higher standard due to local practices. 

Strengthening Practices to Reduce Potential Liability 

To reduce the risk of liability, an organization should concentrate on basic documentation practices that 
clarify what happens to a patient during his or her inpatient stay. Accurate, complete, timely, and 
appropriately detailed documentation becomes significant in legal matters and may reduce organizational 
liability. 


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PUBLIC REPORTING 

Since 2002, a few states have enacted legislation that requires healthcare organizations to publicly 
disclose HAI rates. Similar legislative efforts are under way in several states, including Kentucky. 
Advocates of mandatory public reporting of HAIs believe that making such information publicly available 
will enable consumers to make more informed choices about their healthcare. Advocates also believe 
public reporting of HAIs reduces incidents of infections and improves overall healthcare quality. For 
example, consumer safety advocate organizations spearheaded a program for hospitals in the early 
1990s to publish information about deaths arising from coronary artery bypass graft surgery. That effort 
caused hospitals and surgeons to look at their current practice and make changes to their practices, 
which dramatically lowered mortality rates. Consumer safety groups today draw an analogy to the 1990s 
results, hoping that HAI reporting will cause a similar outcome. 

Consumer safety advocate groups believe that patients have a right to know an organization's infection 
rates, whereas other groups express concern about the reliability of public reporting systems because of 
the variability in system definitions of HAIs, or in the methods and resources used to collect HAI data. 
The challenge for organizations to collect infection data occurs because of an absent standard method 
for counting what actually constitutes an HAI. For example, a hospital may not know if the patient 
acquired an infection before, during, or after a hospital stay. Because of infection-detection difficulties, 
most hospitals choose to monitor procedural outcomes, which account for the majority of infections. 
Mandatory collection of data, especially on a hospital-wide scale, can be quite costly and an 
administrative burden for the organization. 

A voluntary reporting system, relying on incentives to organizations choosing to share data, would 
encourage organizations to track only the most important infection types and allow atypical organizations 
to opt out of reporting. Public reporting of these data may also have negative repercussions. The 
organizations that most diligently report infections will appear to be the least safe, and public reporting 
may also provide incentive for organizations to turn away marginal cases. Concerns also arise if 
organizations receive a poor report card. Leaders fear less-than-desirable outcomes might be used 
against the organization or practitioner in legal proceedings. A confidential report, made to an agency 
with oversight capabilities, is one alternative to public reporting. 

The CDC's Healthcare Infection Control Practices Advisory Committee set policy guidelines in 2005 that 
suggest counting HAIs using public health surveillance methods, creating oversight councils, and 
allowing institutions to preview their data before state agencies make the data public record. Today 
almost every state has either passed or attempted to pass a bill making national public reporting 
inevitable. 

A NATIONAL REPORTING SYSTEM: NSHN PROGRAM GOALS AND 
REQUIREMENTS 

In the early 1970s, the CDC developed the National Nosocomial Infections Surveillance (NNIS) system 
to monitor the incidence of HAIs or nosocomial infections. The Web-based successor to NNIS, the 
National Health Safety Network (NHSN), also a voluntary and confidential system, assists a reporting 
hospital with releasing data to organizations such as state or local health departments and quality 
improvement organizations. NHSN is the only national system that can track HAIs and allow voluntary 
reporting of infections. Many hospitals use NHSN today. The CDC developed the NNIS system to help 
infection prevention professionals and hospitals stay abreast of the rapidly expanding science and 
practice of infection prevention and better manage endemic and epidemic episodes of HAI. The 
principles of the NNIS and NHSN systems are based on CDC's definition of public health surveillance 


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and are divided into the following four objectives: (1) detect and monitor adverse events; (2) assess risk 
and protective factors; (3) evaluate preventive interventions; and (4) provide information to stakeholders 
and partner with them to implement effective prevention strategies. Organizations use the NHSN 
database to: 

• Describe the epidemiology of HAIs. 

• Describe antimicrobial resistance associated with HAIs. 

• Produce aggregated HAI rates suitable for interhospital comparison. 

The CDC requires hospitals participating in NSHN to have sufficient infection prevention personnel to 
collect the data using standardized protocols and numbers of beds to yield enough cases of HAI for 
reliable estimation of the incidence and trends over time. The CDC collects data on HAIs for research 
and investigation, as authorized under Title III, Section 301, Section 304, and Section 306 of the Public 
Health Service Act (42 USC 241, 242b, 242k, and 242m[d]). Because of the sensitive nature of the data, 
the NSHN system guarantees confidentiality for the identity of both the patients and the reporting 
hospital. The CDC analyzes, interprets, and publishes reports of aggregated data but cannot release 
any patient-specific data or any hospital-specific data without written consent of the participating 
hospital. Hospitals may voluntarily release their own NSHN data to anyone they choose. 

DOCUMENTATION 

Incomplete or inaccurate documentation can open an organization or individual up to a whole host of 
legal actions. Many courts decide the outcome of a legal action or regulatory citation on what is or is 
not documented in the patient's medical record. Therefore, healthcare facilities must educate employees 
about the processes and policies in place that promote accurate and comprehensive documentation of 
patient care. The organization should regularly perform open and closed medical record reviews for 
presence of the following: 

• Clear and complete physician orders. Medication orders that include the name of the medication, 
therapeutic dose, time administered, route, start and stop dates, and any specific parameters for 
contacting the physician or withholding the medication. When a physician issues a verbal order to a 
practitioner, the practitioner must always immediately write down the order, read the order back to the 
physician, and verify with the physician that the order is correct. 

• Complete documentation of the medication reconciliation process and patient and family education. 

• Physicians, nurses, and other members of the healthcare team date and time their entries into the 
medical record and legibly sign their entries. 

• The medical record contains a clear account of the patient's condition, including any change in 
condition, response to treatment, ongoing assessments such as the patient's response to pain, and a 
safety assessment. 

• The documentation addresses the medical plan of care and any changes or updates to the care plan, 
including any decisions the patient makes about his or her care. 

• The documentation supports collaboration between disciplines, including outside agencies. 

• The medical record contains clear and effective communication between staff members, other 
disciplines, and the patient's family. 

• A factual description of any event, such as a patient fall or injury, along with appropriate safety 
measures in place to prevent the event from recurring. 


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LEGAL ISSUES OF AN ELECTRONIC HEALTH RECORD 

In an effort to ensure patient safety, most organizations have implemented all or part of an electronic 
health record (EHR) system. Whether an organization buys an entire EHR system, builds and 
customizes their own EHR, or uses a hybrid system, EHRs can improve communication between 
providers about the patient's plan of care. An EHR refers to an individual patient's medical record in 
digital format. EHR systems coordinate the storage and retrieval of individual records accessed on a 
computer over a network. Organizations should follow security rules and take proper safeguards in the 
release of electronic data. Recent federal government initiatives support using EHRs to: 

• Connect clinicians so that they can exchange health information using advanced and secure 
electronic communications; 

• Personalize care with consumer-based health records and better information for consumers; and 

• Improve public health through advanced bio-surveillance methods and streamlining of the collection of 
data for quality measurement and research. 

PATIENT SAFETY 

Everyone in a healthcare institution must take responsibility to assure patient safety. Ensuring patient 
safety includes: 

• Furnishing and maintaining proper equipment, supplies, and services and exercising reasonable care 
in the selection and use of such equipment, supplies, and services. 

• Exercising reasonable care in the selection and retention of appropriate personnel. 

• Exercising reasonable care with respect to the maintenance of buildings and grounds, including 
keeping the environment clean and sanitary with the aim of preventing infection. 

• Complying with policies and procedures, whether established by the institution or outside agencies 
that have as their objective the safety and well-being of patients and the public. 

TJC announces NPSGs annually that healthcare organizations must meet in order to maintain 
accreditation status. Because an NPSG addresses the organization's obligation to establish processes, 
policies, and procedures to protect patients from infections, institutions that fail to establish proper 
procedures and techniques of infection prevention have potential liability when an adverse patient 
outcome occurs that is related to an HAI. In addition, hospitals may have a duty to monitor specific 
infection rates and to intervene immediately if institutional leaders or the IP notices excessively high 
infection rates. 

TJC mandates the presence of an effective institution-wide program for the surveillance, prevention, and 
control of infection. Characteristics of an effective infection prevention and control program include 
written policies and procedures for infection surveillance, and strategies to prevent and control the 
spread of infection to patients, patient care departments, and service areas. Medicare conditions of 
participation for hospitals constitute federal regulations for hospital infection prevention and control 
programs and mandate that hospitals provide a sanitary environment to avoid sources and transmission 
of infections and communicable diseases. 

Physician responsibilities for infection prevention include ensuring appropriate clinical care, serving as a 
member of the hospital's infection prevention committee, or serving as a hospital epidemiologist or 
infection prevention officer. In general, physicians act as a role model for medical asepsis. Physicians 
may incur liability for failing to adhere to appropriate infection prevention standards of care. In addition, 
as the availability of physicians specializing in infectious diseases grows, liability could result for a 

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physician who fails to consult with an infectious disease specialist about a patient with an infectious 
process. 

COMPLIANCE STRATEGIES FOR PATIENT SAFETY AND REDUCING THE 
RISK OF INFECTION 

Each organization should review the NPSGs and associated recommendations and determine how best 
to comply with each of them. Ensuring patient safety makes good business sense and will help 
organizations manage risk. Healthcare organizations are required to establish and maintain infection 
prevention and control programs that provide a safe, sanitary, and comfortable environment for patients. 
The infection prevention and control program should focus on preventing infection and reducing the risk 
and transmission of infection among patients, visitors, and staff members. Elements of the program 
include: 

• Creating a prioritization matrix to determine the top opportunity for improvement that reduces the 
volume of infections or reduces the severity of patient infections and prevents the spread of 
infections. 

• Creating an infrastructure that eliminates the barriers between infection prevention and risk 
management and quality management. 

• Selecting initiatives and developing a practical action plan that uses principles of performance 
improvement. 

• Developing a strategic plan that identifies how to change successful strategies into worthwhile gains. 

• Ensuring healthcare personnel comply with hand hygiene guidelines to prevent cross-contamination. 

• Preventing a patient's exposure to contagious organisms. 

• Ensuring housekeeping efforts follow guidelines for proper cleaning, sterilization, and handling of 
equipment. 

• Ensuring healthcare personnel have protection from exposure to infectious diseases. 

• Conducting surveillance of personnel, reviewing immunization records, and providing employees with 
immunizations if necessary. 

• Ensuring that the ethical issues in infection prevention, including the sensitive nature of sexually 
transmitted diseases, are addressed. 

CREATING THE INFRASTRUCTURE, MATRIX, PRIORITIZING, AND 
DEVELOPING A STRATEGIC PLAN 

Many healthcare institutions are beginning to look at infection prevention as an all-encompassing 
department that requires specialization, training, and certified staff. Institutions create infrastructures that 
allow IPs to function broadly and develop facility-wide infection prevention practices. The infrastructure 
may include the addition of infection prevention educators, special coordinators of initiatives such as the 
programs that manage MRSA episodes, and data collection specialists, to name a few. Often the 
infrastructure requires IPs to interact intensively with medical staff, ancillary departments, hospital 
leadership, quality personnel, and safety and risk management departments. Leaders may give IPs 
authority and consultative roles to change organization-wide processes and practices. 

The IP usually takes the lead to identify infection risk situations and prevention goals by developing a 
matrix that identifies the frequency and severity of each risk. From the matrix, the IP can prioritize 
initiatives to reduce or eliminate high-risk infections, the relative impact on the patient, and preventability 


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to ensure efforts focus on where changes can truly occur. In addition, the IP may choose the Healthcare 
Failure Mode Effect Analysis (HFMEA) to identify possible failure points and reengineer or redesign 
processes. The HFMEA may identify and allow the organization to eliminate areas of liability from 
adverse patient outcomes, such as hospital-associated infections, patient injury, and even death. Finally, 
the organization must include the IP's work and efforts in the overall strategic plan. The strategic plan 
should examine whether the facility has in place ample infection prevention resources, equipment, and 
personnel to achieve the "best practices" standard of care. 

The strategic plan should include interventions to manage multidrug-resistant organisms, often referred 
to as MDROs or "superbugs," such as MRSA and vancomycin-resistant enterococci (VRE). IPs must 
educate employees about how to stop the spread of these organisms. Inservice training sessions 
include the following: 

• Proper hand hygiene procedures 

• Proper environmental cleaning practices 

• Proper sterilization of equipment 

• Use of disposable supplies 

• Proper use and application of personal protective equipment 

• Proper isolation techniques 

Preventing Infection 

PREVENTING CROSS-CONTAMINATION BY COMPLYING WITH HAND 
HYGIENE PROCEDURES 

According to the medical literature, most hospital-associated pathogens are transmitted from patient to 
patient via the hands of healthcare personnel. Hand hygiene, therefore, is the simplest and most 
effective, proven method to reduce the incidence of HAIs. Despite this well-established relationship, 
compliance with hand hygiene among all types of healthcare personnel remains inconsistent. Identifying 
effective methods to improve the practice of hand hygiene can greatly enhance the care of patients and 
result in a significant decrease in HAIs. 

Organizations should have detailed policies in place regarding when healthcare personnel must perform 
hand hygiene, for example, before and after applying gloves and when entering and exiting patient 
rooms. IPs should implement a mechanism of employee surveillance to ensure that healthcare staff 
members actually clean their hands when caring for patients. Other strategies that may facilitate hand 
hygiene and minimize cross-contamination include individual alcohol-based hand rub containers for each 
employee, strategically placed hand rub dispensers inside and outside of patient rooms, rewards for 
compliance with hand hygiene practices, and unit staff members appointed to act as role models and 
hand hygiene champions. 

While the spread of infection to patients decreases with staff adherence to hand hygiene practices, staff 
may experience skin irritation as an adverse effect of the activity. Good skin integrity constitutes an 
important barrier to infection. Soaps and detergents can damage the skin when applied on a regular 
basis. Alcohol-based preparations are less irritating to the skin, and with the addition of emollients, staff 
may tolerate certain products better than others. Another potential barrier to hand hygiene compliance is 
the amount of time required to perform proper hand washing. Current recommendations for standard 


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hand washing suggest 15 to 30 seconds of vigorous friction with soap constitutes adequate hand 
hygiene. Given the many times during a nursing shift that hand hygiene should occur, nurses may argue 
that the time constraints impede their performance to accomplish other patient care duties. In fact, lack 
of time is one of the most common reasons cited for failure to wash hands. Because alcohol-based 
hand rubs require less time, organizations opt to purchase individual bottles of hand rub as a way to 
curtail the time concern. 

COST OF HAND HYGIENE INTERVENTIONS 

Interventions designed to improve hand hygiene require organizations to invest significant financial and 
human resources. Costs develop as a result of educational/feedback initiatives, as well as for 
interventions that require equipment, such as more sinks, automated sinks, or new types of hand 
hygiene products. The costs incurred by such interventions must be balanced against the potential gain 
derived from reduced numbers of HAIs, potentially reduced lawsuits, and reduced staff and patient 
injuries. 

ORGANIZATIONAL BEST EFFORTS 

According to healthcare literature, the best approach to improving hand hygiene compliance involves 
increasing frontline staff awareness. In addition, many organizations review the structural design of 
nursing units, pilot a number of new and innovative hand hygiene products, review workload to 
determine sufficient time to perform hand hygiene, and instill individual accountability to follow hand 
hygiene practices. When and if a lawsuit occurs because of an allegation of an HAI, all legal counsel in 
the litigation will request a timeline and description of the organization's best practice efforts to achieve 
staff commitment to hand hygiene. 

PREVENTING EXPOSURE TO CONTAGIOUS PERSONNEL 

Healthcare organizations in most states conduct some type of health screening for infectious disease for 
their current employees and screen new employees at the time of hire. Medicare and Medicaid 
conditions of participation require that healthcare organizations establish and enforce a continuous 
process for inspection and report any hospital employee with an infection who may be in contact with 
patients, food, or laundry. The organization's failure to recognize obvious symptoms of an employee's 
poor health and to remove the employee from duty may create liability for the organization. As part of a 
facility's duty to provide quality patient care, processes should be in place to detect, reassign, and 
remove contagious staff from direct patient care. 

REDUCING THE RATE OF INFECTION IN THE HOSPITAL: POSTOPERATIVE 
INFECTIONS 

According to conventional literature, experts agree that HAIs represent a worldwide health hazard and 
that HAIs are a major side effect of care and treatment, contributing greatly to morbidity, mortality, and 
the cost of care. Not surprisingly, many of the malpractice claims filed against surgeons involve surgical 
site infections. Many of the organisms that cause postoperative infection are normally present in healthy 
individuals. This premise is often used to counter plaintiffs' allegations of negligence in cases involving 
postoperative infections. For example, in Roark v. St. Paul Fire and Marine Insurance Company , a 
staphylococcal infection occurred in a patient's surgical wound site. Based on a review of the medical 
record and the institution's policies and procedures, the evidence established that physicians and staff 
followed standard procedures to establish the sterility of the supplies and instruments and that the 
environment met or exceeded national standards. An expert witness testified that most individuals who 
contract a staphylococcus infection after surgery have the same bacteria on their skin prior to surgery. 


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Because staphylococcus bacterium is found within the subcutaneous sweat glands and hair follicles of 
some patients, the organism may survive skin cleansing performed before surgery. A physician testified 
that susceptibility to staphylococcal infection varies from individual to individual and that there is no 
practical way to determine, prior to surgery, who may be more susceptible to staphylococcus infection or 
who may be a carrier of the bacteria. The expert witness concluded that staphylococcal infections are 
an unavoidable risk of surgery. 

INFECTIONS DUE TO MEDICAL EQUIPMENT AND DEVICES 

Hospitals must ensure that staff follows proper procedures for cleaning, handling, storing, and sterilizing 
equipment and supplies. Thus, infections caused by contaminated instruments, equipment, or appliances 
may result in liability for the organization. Such cases often involve the use of improperly sterilized 
needles or unclean catheters. For example, in Ernest Chester v. Mercy Catholic Medical Center of 
Southeastern Pennsylvania, a patient developed a staphylococcal infection that caused cardiomegaly (an 
enlarged heart) and mitral valve prolapse. The patient claimed the infection was caused by improper 
catheter placement and failure to monitor the patient's condition, which resulted in contamination of the 
intravenous catheter entrance site. The patient also claimed that physicians did not properly diagnose 
the infection. The case ended with an undisclosed settlement to the patient. 

In another case, Rung v. St. Luke's Memorial Hospital Center, a physician assistant used an unsterile 
needle to administer a tetanus shot to a patient. The patient claimed that the physician assistant's infant 
son touched the needle prior to the injection. The patient further claimed that she requested a different 
needle be used but that the physician assistant assured her there was no need to be concerned. The 
patient claimed that as a result of the contaminated needle, the medical staff was negligent in giving the 
injection, and she experienced a chronic infection resulting in permanent pain and loss of the use of her 
left arm. The jury ruled in the patient's favor, and the court awarded the patient $1,889,700. 

Another landmark case involving medical equipment and devices is Brick v. Greenbriar Nursing Home. 

An 83-year-old woman recuperating from colitis required a central venous catheter to administer 
nutrition. A nurse at the facility attempted to irrigate the catheter and in doing so noticed a break in the 
catheter. The nurse applied adhesive tape over the broken area. Subsequently, the patient developed a 
staphylococcus infection in her lungs and sustained neurological damage that affected her mobility and 
her ability to care for herself. The defendant nursing home claimed that the infection was a known risk 
of catheter use and that the infection may have occurred despite the break in the device. The parties 
settled before trial for the sum of $450,000. 

The reuse of disposable, single-use medical devices can be problematic. Some institutions reuse 
devices such as hemodialyzers, transducer domes, balloon-tipped catheters, cardiac catheters, catheter 
guide wires, biopsy needles, endotracheal tubes, anesthesia face masks, irrigating syringes, and manual 
resuscitators. TJC requires that a facility have in place written policies and procedures addressing the 
reuse of disposable items, and that these policies and procedures address the reprocessing of 
disposable items to be reused. When medical devices and equipment apparatus are explicitly labeled 
"for single use only," hospitals and physicians open themselves up to liability if they use the device more 
than once and the patient experiences a less-than-desirable clinical outcome. Guidelines and protocols 
regarding reusable products should be established, and the hospital should keep detailed records to 
substantiate that reuse does not jeopardize patient care. 

ANTIBIOTICS 

The use or inappropriate use of antibiotic medication can become a legal issue in healthcare and result 
in litigation. Lawsuits alleging negligence on the part of the practitioner focus on: 


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• Failure to prescribe indicated antibiotics. 

• Failure to adequately screen for sensitivity or properly monitor antibiotics use. 

• Prescribing antibiotics that are clinically contraindicated. 

• Inappropriate use of antibiotics for surgical prophylaxis. 

• The subtherapeutic use of antibiotics. 

In principal, it may be possible for a patient who develops an HAI caused by a resistant organism to 
recover damages resulting from the organism's resistance, if he or she can prove that the resistance 
was caused by the physician or hospital's indiscriminate use of antibiotics. In hospitals where antibiotic 
use is not left entirely to the discretion of individual physicians and where the hospital can take 
affirmative steps to control the use of antibiotics, legal exposure may extend to the hospital. Most 
hospitals now curtail liability and promote patient safety by using information technology that improves 
patient safety, such as computerized physician order entry systems and bar coding. These sophisticated 
systems provide physicians with choices for approved antimicrobial selection of medication, alert 
clinicians to allergic reactions, and provide for appropriate discontinuation of antibiotics according to 
national guidelines. Bar coding allows the clinician to scan a bracelet on the patient and a bar code on 
the medication validating that he or she administers the right medication to the right patient. Information 
technology helps to prevent adverse drug reactions, ensures timely medication administration, and 
prevents "near misses" as long as clinicians use the system as intended, without overriding or working 
around the safety alerts. 

Standardization of systems also reduces liability for healthcare organizations. Institutions should review 
infection prevalence and current practice, look at best practice to improve performance, and provide 
staff with clear policies, procedures, and clinical guidelines to assure consistency in care. The infection 
prevention department may require that the medical staff, a medical staff committee, or hospital clinic 
teams regularly conduct a clinical review of policies governing antibiotic use. The work of the review 
may consist of: 

• An assessment of clinical aspects of infections occurring in the facility. 

• A review of pharmacy data determining antibiotic use. 

• A pathogen resistance trend report from the hospital microbiology laboratory. 

• Institutional observations, actions, and recommendations regarding antibiotic use. 

• Restricting the use of a particular antibiotic if appropriate. 

Institutions that proactively standardize policies for antibiotic use, track and trend antimicrobial data, and 
identify processes and practices for improvement will enhance the overall infection prevention program. 

PROTECTING HEALTHCARE PERSONNEL AND THIRD PARTIES FROM 
EXPOSURE TO INFECTIOUS DISEASES 

The standards of the Occupational Safety and Health Act (OSFIA) of 1970 ensure a safe and healthy 
work environment for employees. OSHA designed rules to minimize on-the-job risks for employees, 
including: 

• Limiting exposure to toxic chemicals. 

• Limiting exposure to infectious diseases. 

• Limiting exposure to hazardous waste materials. 


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• Limiting exposure to hazardous equipment. 

Healthcare institutions have a duty to protect the health of employees from exposure and injury. 
Healthcare personnel may be exposed to a wide array of health and safety hazards, including exposure 
to biologic agents, physical agents, stress, injury, and chemical agents. Under common law, employers 
must provide reasonably safe working conditions for their employees and must warn employees of 
unsafe conditions that they might not discover on their own. OSHA's general duty clause mandates each 
employer furnish to employees a place of employment that is free of recognized hazards that may 
cause, or are likely to cause, death or serious physical harm to the employee. Violations of this 
provision may result in heavy fines for the organization. In one provision of the law, OSHA possesses 
broad powers to investigate workplaces, review employer records, and conduct medical examinations to 
ensure that employees have a safe workplace. 

In October 1993, OSHA issued an enforcement policy regarding occupational exposure to 
Mycobacterium tuberculosis (TB). The policy emphasizes that providers should: 

• Implement control measures, including administrative and engineering controls and personal 
respiratory protection. 

• Conduct risk assessments and develop a written TB control plan. 

• Ensure early identification and management of individuals with TB. 

• Provide purified protein derivative skin-testing programs. 

• Develop educational programs for healthcare personnel. 

CONDUCT SURVEILLANCE OF PERSONNEL AND REVIEW IMMUNIZATION 
RECORDS 

State laws addressing workers' compensation ordinarily cover an employee's lost time and medical care 
when the employee can prove he or she contracted the disease in the workplace. The employee may 
receive payment and compensation without proving fault or negligence on the part of the employer. In 
certain circumstances, employees who acquire work-related infections may be eligible for remuneration 
beyond what the workers' compensation system provides, if the employee can establish that the 
employer intentionally disregarded the risk of infection in the workplace. If an employee becomes 
infected with human immunodeficiency virus (HIV) in the course of employment, workers' compensation 
benefits may apply if the worker can demonstrate a causal connection between his or her HIV infection 
and employment. Specifically, the employee would need to prove that the incident occurred on the job 
involving a documented needlestick injury, puncture wound, or other exposure to HIV-contaminated 
blood or body fluids. Providers routinely conduct a health inventory on all new employees that includes 
immunization status and past health conditions that predispose the employee to certain communicable 
diseases. The health inventory guides an employer to determine whether an employee is at risk for 
disease. 

Healthcare providers should monitor employees for the presence of infectious diseases or whether an 
employee is predisposed to or a carrier of infectious disease. Employers should make special efforts to 
monitor staff in high-risk areas, such as hemodialysis units. As pathogens such as HIV and Hepatitis C 
become prevalent in healthcare settings, healthcare providers should develop a comprehensive 
surveillance system for healthcare personnel in order to track and trend disease occurrences. Whether 
or not a provider knows that an employee has an infection, the organization should take steps to protect 
patients and other healthcare personnel from infection. Providers should rigorously monitor and enforce 


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compliance with CDC guidelines to reduce the risk of patients' exposure from healthcare personnel, 
including physicians. 

In 1991, OSHA published regulations designed to reduce the risks of infection from bloodborne 
pathogens. This standard is the most pervasive regulation that OSHA imposed on healthcare 
organizations. The regulations apply to all occupational exposures from blood and other body fluids. 
Although most healthcare organizations comply with universal precautions, OSHA regulations mandate 
several additional guidelines: 

• Develop an exposure control plan to eliminate or minimize exposure. 

• Make Hepatitis B vaccine available to all employees at risk for exposure. 

• Ensure that an employee exposed to an infectious agent receives testing to determine the presence 
of the organism and provide the employee with follow-up treatment and counseling. 

• Implement certain engineering and work practice controls to eliminate or minimize job risks. 

• Store and maintain sharps or contaminated materials in accordance with regulations. 

• Communicate to employees and the public the nature of contaminated waste by affixing appropriate 
labels bearing biohazard symbols. 

• Provide inservice training sessions for all employees at the time of initial employment and no less 
than annually thereafter. 

• Maintain accurate and confidential records related to personnel training, vaccination, and 
management of exposures. 

An example of the application of these standards occurred in 1994 at AmeriCare, a New Hartford, New 
York staffing agency. The agency received a citation for an alleged violation of OSHA's bloodborne 
pathogens standard. The firm received a $44,000 fine for failing to offer Hepatitis B vaccinations to 
employees who had been exposed to blood and other infectious materials. In addition, AmeriCare failed 
to include all required information in its written exposure control plan. 

EMPLOYEE EXPOSURE AND TESTING 

The social stigma associated with acquired immunodeficiency syndrome (AIDS) has added to the 
dilemma healthcare organizations face regarding workers accidentally exposed to a patient's blood and 
body fluids. Although workers' compensation laws may pay the medical expenses of testing and 
treatment, employees often try filing legal claims outside the workers' compensation system for negligent 
failure to disclose harmful conditions at the workplace, malicious intent to conceal harmful risks, or 
failure to use due care in keeping the workplace safe. 

The CDC recommends that after a healthcare professional experiences a parenteral or mucous 
membrane exposure to blood or other body fluids, or has a cutaneous exposure involving large amounts 
of blood, the facility should inform the patient of the exposure and obtain the patient's consent to be 
tested for serologic evidence of HIV. If the patient is positive for HIV or refuses HIV antibody testing, the 
healthcare professional should be counseled and evaluated clinically and serologically for evidence of 
HIV infection as soon as possible after the exposure. If the patient is seronegative, the healthcare 
professional should still receive a baseline HIV antibody test. The CDC recommends that no further 
follow-up of the exposed professional is necessary unless the patient is at high risk of HIV infection. 
Because of heightened employee concern, many hospitals have chosen to make serologic testing 
available to all personnel who fear they have been exposed/infected. 


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If the patient, after being informed of the incident, refuses HIV testing, the hospital's options depend on 
state law. Some states forbid testing without written informed consent. In Colorado and Florida, state 
law expressly allows testing, regardless of consent within certain guidelines. In at least two states 
(Florida and Maine), a court order may mandate patient testing. 

WHEN AN EMPLOYER DISCOVERS AN EMPLOYEE HAS AN INFECTION 

Employers may need to determine what to do when they learn that an employee has an infection such 
as HIV. Employers often face a difficult dilemma deciding between facing charges of employee 
discrimination and facing repercussions that stem from an unknowledgeable public. Once a provider 
learns an employee has an infection, a representative should approach the employee confidentially and 
with sensitivity to determine the appropriate action to protect the employee, other healthcare personnel, 
and the patient population from transmission of infection. 

The provider and employee should take reasonable protective measures that include limiting employee 
tasks to noninvasive procedures, ensuring that the employee wears double gloves at work, and ensuring 
that other elements of the exposure control plan are in place. When an employee does not agree with 
the procedures that the provider deems necessary, comments and actions of the provider and employee 
should be fully documented. After consideration of the accommodation efforts for the employee, 
balanced with consideration of patient safety, the employer may proceed with disciplinary action and/or 
employment termination if the employee refuses to comply with the exposure control plan. 

EMPLOYEE INSISTENCE REGARDING PRECAUTIONS 

An employee may lawfully refuse to work in unsafe conditions and may also insist on wearing safety 
equipment on the job. OSHA does not permit employees to leave the job because of potentially unsafe 
working conditions. Rather, employees must inform their employer of the unsafe conditions or request 
an OSHA inspection of the workplace. If an employee is confronted with a condition presenting a real 
danger of serious injury or death, he or she may refuse in "good faith" to work until the employer 
removes the danger. To protect employees, the employer uses the reasonableness standard and 
removes hazards that (1) a reasonable person would believe presents a real danger of death or serious 
injury, and (2) causes danger of such an urgent nature. 

When an employee insists on wearing more protective gear than the employer healthcare provider 
believes is necessary to prevent disease transmission, the employer must investigate the employee's 
rationale for wanting additional protective gear and educate employees regarding appropriate infection 
prevention techniques. If, after this process, the employee still insists on following procedures contrary 
to the recommended approach, legal advice should be sought regarding state law on the subject. Some 
state and federal statutes forbid discrimination against an employee for complaining about health 
hazards, even if there is no actual danger, as long as the employee has a reasonable belief that a 
danger exists. 

Although the number of guidelines regarding patient care and employee health may seem overwhelming, 
it is important to realize that improvements in OSHA's guidelines have contributed to making the 
workplace safer, minimizing risks, ensuring proper infection prevention practices, eliminating employee 
discrimination, and improving the overall quality of healthcare. 

FEAR OF DISEASE CLAIMS 

Increasingly, hospitals and physicians face claims for mental distress engendered by the mere possibility 
that a person may experience physical injury in the future. Examples of such allegations in the 


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healthcare context are fear of AIDS claims, which require particularly close analysis. In most states that 
allow fear of AIDS claims, the reasonableness of such claims depends not only on the existence of a 
physical injury, but also on whether the plaintiff was actually exposed to HIV. Some states, such as 
Florida and Tennessee, require the plaintiff to prove actual exposure to HIV, not the mere possibility of 
exposure, before they will allow recovery in fear of AIDS claims. Other states, such as Maryland and 
Virginia, do not require actual exposure but will allow recovery for the window of anxiety between the 
time the plaintiff learns of their possible exposure to HIV and the time he or she receives negative test 
results. In order to ensure that such claims are genuine, most jurisdictions still require certain minimum 
levels of proof, such as: 

• Whether actual or only possible exposure occurred. 

• Whether an emotional injury occurred. 

• Whether the claimant will actually develop the feared condition. 

• Whether a reasonable "window of anxiety" exists with which to mitigate damages. 

Ethical Issues 

OBLIGATION TO DISCLOSE TO PATIENTS THE PRESENCE OF A 
HEALTHCARE-ASSOCIATED INFECTION 

In 2000, the Institute of Medicine released a report about the quality of healthcare titled To Err Is 
Human: Building a Safer Health System. This publication created public awareness about medical errors 
and the lack of safety in the nation's healthcare system. Thus, patients and family members requested 
to know more about what happens or happened during a stay in a healthcare facility. Research 
suggests that patients and the public support disclosure. The National Patient Safety Foundation urges 
healthcare professionals to disclose to patients errors and adverse events and be forthcoming about 
patient injuries and care complications when they occur. Ethical and professional guidelines recommend 
disclosure of medical errors and support informing patients about their care, treatment, and services. 

Providers should inform patients when an HAI occurs. Courts have become increasingly insistent that 
physicians have a duty to fully disclose all pertinent facts concerning a patient's condition, even if the 
physician is convinced that he or she is acting in the patient's best interest by remaining silent. The 
informing obligation exists regardless of whether the condition is the result of negligence of the 
physician, a colleague, or the hospital. Failure to inform patients in such situations may result in liability 
for fraud, negligence, or conspiracy. Punitive as well as compensatory damages may be awarded in 
such situations. 

DUTIES TO NONPATIENTS 

Providers' obligations to inform individuals of a communicable disease situation extend to persons other 
than patients. A duty of reasonable care extends to all employees, volunteers, and visitors on the 
premises. An individual who visits a hospital or medical facility during regular visiting hours and remains 
on the premises is an invitee to whom the hospital owes the duty of exercising ordinary care. If a third 
party develops an infection from a patient because of the provider's negligence, case law has 
established that damages may be awarded to the third party. Visitors of isolated patients, for example, 
should be warned of the risk of contracting the disease, and physicians and staff should document in 
the medical record that the visitor was so advised. 


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In the case of Johnson v. West Virginia University Hospitals, Inc.,a university police officer was called 
upon to help restrain a combative patient and subsequently received a human bite from the patient on 
his forearm. After the bite, the officer learned that hospital personnel knew the patient had AIDS. The 
officer sued the hospital for negligence, asserting that the hospital failed to advise him in advance that 
the patient had AIDS and that, as a result of the exposure to AIDS, he experienced emotional distress. 
The jury returned a verdict in the officer's favor for $1.9 million. 

In 1993, the Tennessee Supreme Court expanded the duty to protect third parties from exposure to 
communicable diseases through a ruling that imposed liability on a physician to warn a patient's family 
members of the risk of the patient's noncontagious disease. A couple whose son died of Rocky 
Mountain spotted fever sued the physician for negligence because the physician failed to warn the 
mother that she also was at risk of contracting the disease. The physician argued that since the mother 
was not his patient and Rocky Mountain spotted fever is not contagious from human to human, there 
was no duty to warn of the risk of exposure. The Supreme Court found that individuals who come in 
contact with the disease are at risk of carrying the disease and that the existence of the physician- 
patient relationship is sufficient to impose upon a physician an affirmative duty to warn identifiable third 
persons in a patient's immediate family against foreseeable risks emanating from a patient's illness. 
Clearly, the Tennessee Supreme Court's interpretation of the ruling suggests that physicians and 
healthcare personnel have a duty to protect the patient and the patient's family if they are at risk for 
contracting a disease. The premise that care is extended beyond the patient places the onus on 
healthcare professionals to thoroughly assess the patient's physical and social environment. 

INFORMED CONSENT 

Informed consent means an agreement to do something or to allow something to happen, made with 
complete knowledge of all relevant facts, such as the risks involved or any available alternatives. For 
example, a patient may give informed consent to medical treatment only after the healthcare 
professional has disclosed to the best of his or her knowledge possible risks involved in accepting or 
rejecting the treatment. A healthcare provider or facility may be held responsible for an injury caused by 
an undisclosed risk. According to the American Medical Association (AMA), informed consent is more 
than simply getting a patient to sign a written consent form. Informed consent is a process of 
communication between a patient and physician that results in the patient's authorization or agreement 
to undergo a specific medical intervention. 

In the communications process, physicians providing or performing the treatment and/or procedure 
should disclose and discuss with the patient: 

• The patient's diagnosis, if known; 

• The nature and purpose of a proposed treatment or procedure; 

• The risks and benefits of a proposed treatment or procedure, including the risk of contracting an 
infection; 

• Alternatives (regardless of their cost or the extent to which the treatment options are covered by 
health insurance); 

• The risks and benefits of the alternative treatment or procedure; and 

• The risks and benefits of not receiving or undergoing a treatment or procedure. 

In turn, the patient should have an opportunity to ask questions to elicit a better understanding of the 
treatment or procedure so that he or she can make an informed decision to proceed or to refuse a 
particular course of medical intervention. 


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The informed consent communications process or a variation thereof is both an ethical obligation and a 
legal requirement spelled out in statutes and case law in all 50 states. Providing the patient relevant 
information has long been a physician's ethical obligation. The first case defining informed consent 
appeared in the late 1950s. Earlier consent cases were based in the tort of battery, under which liability 
was imposed for nonpermitted touching. Although battery claims occasionally occur when treatment is 
provided without consent, most consent cases generally center around whether the consent was 
"informed" (e.g., whether the patient was given sufficient information to make a decision regarding his or 
her body and healthcare). To avoid litigation, clinicians must know the importance of clear 
communication and how to document the communication process. Good documentation can serve as 
evidence that informed consent indeed took place. A timely and thorough documentation in the patient's 
chart by the physician providing the treatment and/or performing the procedure is evidence that the 
physician engaged the patient in an appropriate discussion. A well-designed, signed informed consent 
form may also be useful, but an overly broad or highly detailed form actually can work against the 
organization. 

Forms that serve mainly to satisfy all legal requirements and contain broad language such as "all 
material risks have been explained to the patient" may not preclude a patient from asserting that actual 
disclosure did not include risks that the patient unfortunately discovered after treatment. At the other 
extreme, listing all of the risks may not be wise. A comprehensive listing of risks will be difficult for the 
patient to understand, and any omission from the list will likely be presumed undisclosed. To establish 
patients' awareness of hospital infections, some attorneys suggest that hospital admission consent forms 
include the risk of infection associated with any hospitalization and should state that the hospital cannot 
ensure that the patient will not contract an infection. Operative consent forms in many hospitals mention 
infection as a possible complication of surgical procedures. 

AN OBLIGATION TO PROVIDE CARE TO ALL 

Patients with incurable infections may find access to healthcare services difficult. Historically, private 
hospitals did not have a legal obligation to accept nonemergency patients. However, in reaction to legal 
theories, statutes, and licensing agency regulations, the traditional rules governing a hospital's 
responsibility in this area have changed. Mandated in most states laws, hospitals must provide 
emergency care whenever requested. Denials of care to patients based on such factors as race or 
handicap are illegal. Any hospital that receives federal financial assistance has an obligation under 
Section 504 of the Federal Rehabilitation Act of 1973 to provide nondiscriminatory treatment. Thus, if 
the hospital staff member refuses to care for a patient with a contagious disease, the hospital has a 
responsibility to see that care is rendered, even if this means transferring the patient to another facility 
for patient care. Although there is generally no duty for a hospital to provide nonemergency services, 
failure to follow established hospital policy, such as hospital admission policies as related to race, sex, 
age, religion, or national origin, may result in liability under state and federal discrimination statutes. 

Healthcare organizations must address personnel who refuse to care for patients with infectious 
diseases. The provider's personnel policies and procedures or employee handbook must describe 
administrative and human resource options or penalties if an employee refuses patient care. Employees 
should be reminded that the healthcare institution provides personal protective equipment, such as 
gowns, gloves, masks, and goggles, to protect them from transmission of infectious diseases. 

Healthcare institutions may attempt to accommodate an employee through reassignment, education, and 
counseling. 

ETHICAL ISSUES AND CONFIDENTIALITY 


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The U.S. Department of Health and Human Services (HHS) issued the Privacy Rule to implement the 
requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA or The Act). 

HIPAA standards address the use and disclosure of individuals' health information, called protected 
health information, by organizations subject to the Privacy Rule, called covered entities, as well as 
standards for individual's privacy rights to understand and control how his or her health information is 
used. Within HHS, the Office for Civil Rights (OCR) has responsibility for implementing and enforcing the 
Privacy Rule with respect to voluntary compliance activities and civil money penalties. 

HIPAA assures that covered entities properly protect an individual's health information while allowing the 
flow of health information necessary to provide and promote high-quality healthcare. HIPAA strikes a 
balance between using information for care, treatment, and services, and protecting the privacy of 
people who seek medical care. Given that the healthcare marketplace is diverse, HIPAA is designed to 
be flexible and comprehensive to cover the variety of uses and disclosures. 

Subtitle F of HIPAA addresses administrative simplification and encourages development of a health 
information system through established standards and requirements for the electronic transmission of 
certain health information. Organizations must implement policies and procedures to protect healthcare 
information and ensure compliance with HIPAA. IPs must ensure that proper disclosure of protected 
health information is done with diligence to protect patient confidentiality. IPs who report information for 
public disclosure should be aware that wrongfully disclosing individually identifiable health information 
violates HIPAA and could result in civil money fines against the organization. HIV antibody testing raises 
a number of legal issues. Healthcare providers are drawn into the debate about testing all hospitalized 
patients for HIV. The balancing of the rights of the infected and the rights of the uninfected to exercise 
self-protection is at the core of this issue. State laws differ on the treatment of this information, and 
many legislative proposals have been introduced at the state and federal level regarding confidentiality; 
thus, providers should remain current regarding evolving law in this area. 

Discrimination against individuals who have AIDS or an HIV infection may occur because of the social 
stigma associated with the condition. Courts could hold a hospital liable for violating the Americans with 
Disabilities Act (ADA) if the hospital refuses to treat an individual with AIDS. For example, in Glanz v. 
Vernick, the hospital refused to perform a surgical procedure on a person diagnosed as HIV positive. 
The patient sued both the hospital and the physician who refused to operate, alleging that the medical 
team and institution discriminated against him on the basis of a handicap. 

Physicians' obligation to treat HIV-infected patients should be addressed by institutional and medical 
staff policies. Some surgeons have publicly announced their refusal to operate on HIV-infected patients. 
Others physicians argue that patients should be treated based on their clinical condition. If such a 
patient is judged to be a candidate for cardiac surgery, for example, neither AIDS nor HIV infection 
should, in and of itself, prevent the surgery from occurring. 

Although healthcare institutions cannot require physicians to accept AIDS or HIV patients in their private 
practices, the legal and ethical principles that require employees to provide care to AIDS and HIV 
patients applies to physicians who work in institutions. For example, a hospital's duty to treat emergency 
patients and to render appropriate care to admitted patients should have policies establishing the 
physician's obligation to treat all patients. 

AIDS patients are entitled to competent medical care with compassion and respect for human dignity. A 
physician may not ethically refuse to treat a patient whose condition is within the physician's current 
realm of competence solely because the patient is seropositive. Medical ethics do not permit categorical 
discrimination against a patient based solely on his or her seropositivity. A person with AIDS needs 


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competent, compassionate treatment. A physician who is not able to provide the care and services 
required by an individual with AIDS should make an appropriate referral to physicians or facilities that 
are equipped to provide such services. Until the hospital and physician accomplish the transfer to 
another facility, the physician must care for the patient to the best of his or her ability. 

In 1991, Dr. Nancy Rockmore Angoff published an article in the Yale Journal of Biology and 
Medicine titled "Do Physicians Have an Ethical Obligation to Care for Patients with AIDS?" Dr. Angoff 
suggests that before antibiotics, physicians took personal risks caring for patients. With the advent of 
AIDS, however, many healthcare personnel were not only unwilling to treat this incurable contagious 
disease because of fear of this deadly virus, but also because of the social stigma associated with the 
patients who contracted the virus (usually homosexuals and intravenous drug abusers). Dr. Angoff 
believes that each medical student, resident, and physician must come to terms with his or her feelings 
about caring for patients with this disease. The 40-page article examines in depth the ethical nature of 
an obligation to care for AIDS patients and concludes that a commitment to care for patients with AIDS 
does indeed exist. The practice of medicine itself and the physician-patient relationship are part of the 
physician's ethical responsibility to act always with concern for the well-being of the patient.lln 1997, the 

AMA's Council on Ethical and Judicial Affairs issued a statement that physicians have an obligation to 
treat AIDS- and HIV-infected patients. Looking broadly at the issue of a duty to care for patients, legal 
scholars and medical professionals consider ethics in any situation when physicians treat patients with 
infectious diseases, including polio, tuberculosis, MRSA, and VRE. 

INFECTION PREVENTION COMMITTEE REPORTS 

According to TJC, hospital infection prevention and control programs should include a multidisciplinary 
committee that monitors infection rates, institutes prevention practices, and conducts surveillance of 
infections. Plaintiffs' attorneys may become interested in the proceedings, records, and reports of these 
committees. Accordingly, protection of patients' confidentiality, names of personnel involved in hospital 
infection surveillance, and the infection prevention reports themselves have become controversial issues 
in terms of the discovery of these reports. Courts have sought to balance the desire of infection 
prevention personnel to maintain confidentiality with plaintiffs' need for information to support their 
allegations. In response to court decisions that have found infection prevention and control program 
records discoverable, the majority of states have enacted statutes to protect such records. 

The New Hampshire Supreme Court ruled that the defendant hospital's infection prevention committee 
minutes and epidemiologist's report were privileged and not subject to disclosure in an action brought by 
a patient diagnosed with herpes after giving birth at the hospital. The concerns of the patient's husband 
led the hospital nurse epidemiologist to conduct an investigation and report to the infection prevention 
committee whether the patient could have contracted the infection while in the hospital. State statutes 
indicate records created to evaluate patient care for quality assurance purposes are privileged. The trial 
court found that the privilege applied only to committee records related to quality assurance and since 
the hospital had separate quality assurance and infection prevention committees, the records were not 
privileged. However, the Supreme Court found the infection prevention committee met a definition of a 
quality assurance committee and that the reports were privileged because the infection prevention 
committee served a quality assurance function when it investigated the source of the plaintiff's infection. 

RISK MANAGEMENT 

Risk management functions encompass activities that are intended to conserve financial resources from 
loss. TJC mandates that hospitals have a safety and risk management program in place to provide a 
physical environment free of hazards and to manage staff activities to reduce the risk of human injury. A 


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risk management program must involve a risk assessment of the buildings, grounds, equipment, 
occupants, and internal systems plus policies and procedures for the timely reporting and resolution of 
situations that pose an immediate threat to life, health, or property. An effective risk management 
program includes the following components of risk identification, risk analysis, risk control, and risk 
financing. 

• Reducing financial losses through effective investigation and management of claims. 

• Developing a patient representative program. 

• Reviewing and coordinating insurance programs. 

• Inspecting the premises and discovering deficiencies in the physical plant. 

• Reviewing policies and procedures to reflect acceptable quality of care. 

• Investigating adverse incidents and reviewing incident reports. 

• Reviewing patient grievances. 

• Conducting educational programs to minimize future risks. 

• Conducting root cause analysis to determine what contributes to an adverse event. 

The risk manager must work closely with the IP to identify, monitor, and control HAIs. A facility should 
adopt a team approach to control the spread of disease and prevent further outbreaks. Both risk 
management and the IP can handle matters such as noncompliance with infection prevention 
procedures, breaks in sterile technique, or equipment contamination. The infection preventionist should 
inform the risk manager of incidents such as: 

• Preventable infections 
. HAIs 

• Infections that could lead to a malpractice claim 

• Infections that contribute to the death of a patient 

In addition, risk management and infection prevention should collaborate to identify high-risk patients, 
such as neonates, the elderly, patients in burn units or the ICU, or patients undergoing a specific 
procedure who appear at risk for infection. IPs should institute a surveillance and screening program to 
monitor patient outcomes and should consider the following: 

• Whether risk factors exist before surgery. 

• Whether early identification of infected patients reduces further infection or cross-infection. 

• Whether isolation or barrier protection prevents cross-infections. 

• Whether patient care areas have adequate infection prevention devices and supplies. 

• Whether the institution empties infectious waste containers in a timely manner in accordance with the 
hospital's hazardous materials and waste program. 

• Whether the organization has effective cleaning products or techniques, equipment, and supplies for 
sterilization, disinfection, and decontamination purposes. 

• Whether written policies and procedures address reusable and disposable items and the shelf life of 
all stored sterile items. 

• Whether written policies and procedures address the appropriate handling of soiled and clean linen. 

• Whether written guidelines address infection prevention in anesthesia, surgery, and post-anesthesia 
care areas. 

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• Whether infection prevention education exists for healthcare personnel at the time of orientation and 
at least annually. 

• Whether staff complies with organizational policies and procedures. 

Collaboratively, the IP and risk management department should develop policies and procedures to 
identify infection risk and limit the spread of infectious diseases among personnel. Periodically, risk 
management should review OSHA regulations pertaining to bloodborne pathogen exposures and 
communicate to the infection preventionist changes in regulation. 

RECENT REGULATORY CHANGES AND FUTURE IMPACTS 

On August 22, 2008, CMS published in the Federal Register its final rule on the 2008 Medicare hospital 
inpatient prospective payment system (IPPS). The CMS rule says that IPPS payment reforms restructure 
the inpatient diagnosis-related groups (DRGs) to account more fully for the severity of each patient's 
condition. In addition, the rule includes important provisions to ensure that Medicare no longer pays for 
the additional costs of certain preventable conditions, including infections acquired in the hospital. Other 
provisions of the rule explain: 

• Payments to all hospitals will increase by an estimated average of 3.5 percent for fiscal year 2008, 
when all provisions of the rule are taken into account, primarily as a result of the 3.3 percent market 
basket increase. 

• Payments will increase for hospitals serving more severely ill patients and decrease for those serving 
patients who are less severely ill. 

• New methodologies will calculate outlier payments and capital cost reimbursement, which are intended 
to be more accurate. 

• No payment to organizations for never events means a provision of the Deficit Reduction Act of 2005 
will prevent Medicare from giving hospitals higher payments for the additional costs of treating a 
patient who acquires a condition (including an infection) during a hospital stay. 

• The Deficit Reduction Act requires hospitals to begin reporting secondary diagnoses that are present 
on a patient's admission. Beginning in 2009, hospitals will not receive payment at a higher rate unless 
the hospital determines that a patient has a condition present on admission. 

• New reportable quality measures in 2008 qualify hospitals for the full market basket update in fiscal 
year 2009. Failure to report certain measures will result in a 2 percent penalty. 

• CMS will measure 30-day mortality for Medicare patients with pneumonia and will develop reportable 
measures of surgical care. 

The effect of federal regulations causes transparency about where and when a patient develops a 
condition and possibly how and what caused the condition. With transparency also comes the possibility 
that patients or family members will hold medical institutions accountable for healthcare outcomes. 

Conclusions 

Healthcare providers and facilities owe a legal duty of care to their patients. Healthcare providers must 
exercise that degree of care and skill that could reasonably be expected of a normal, prudent 
practitioner, and they also have an ethical obligation to act in the patient's best interests. Similarly, 
healthcare facilities have an obligation to provide a safe environment to protect patients from harm in 
the course of receiving care. They have a duty not only to establish necessary systems and protocols to 


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promote patient safety, but also to take reasonable steps to ensure that the healthcare staff complies 
with systems, protocols, policies, and procedures. 

In the context of HAIs, what constitutes reasonable practices and protocols may be a moving target 
during an outbreak, particularly as infection prevention measures are revised to reflect new evidence 
about disease virulence, transmission routes, and key control methods. The area of infection prevention 
is one dominated by guidelines and directives, and failure to comply with recommended practices will be 
one factor that may indicate a failure to meet an appropriate standard of care. In many areas of 
practice, courts often look to guidelines or standards of practice to help determine the legal standard of 
care. Summarizing lawsuits that have stemmed from alleged lapses in infection prevention practices help 
IPs identify legal duties that healthcare providers and facilities owe to patients to ensure their safety. 

If a patient has been harmed or exposed to risk of harm, providers have a duty to disclose that 
information to the patient or family. When errors have occurred, or when some risk of harm exists, 
state, federal, and local laws guide disclosure of patient identifiable health information to regulatory 
authorities, accrediting bodies, or other government agencies. 

The information in this chapter does not constitute legal advice. IPs and healthcare organizations should 
consult with legal counsel regarding specific infection prevention questions or concerns. 

Case Law 

Brick v. Greenbriar Nursing Home , No. 94-00755 (Dade County Cir. Ct. 1994) reprinted in 3 Medical 
Malpractice Verdicts, Settlements, & Experts 31-32 (March 1995). 

Chester v. Mercy Catholic Medical Ctr. of So.E. Pa., No. 2555 (Phila. County C.P. May 1984). 

Chestnut Hill Hosp. v. Workmen's Compensation App. Bd., 551 A.2d 683 (Pa. Commw. Ct. 1988). 

Glanz v. Vernick, 756 F. Supp. 632 (D. Mass. 1991). 

Hellwig v. Potluri,\NL 285712 (Ohio 7th Cir. Ct. App. 1991) (holding a defendant emergency-room 
physician liable for failing to prescribe antibiotics after the plaintiff stepped on a rusty nail). 

In re K., 561 A.2d 1063 (N.H. 1989). 

Johnson v. W. Va. Univ. Hosp. Inc., 413 S.E.2d 889 (W. Va. Super. Ct. App. Nov. 21, 1991). 
Lawlor-Covell v. Wack, M.D.,No. CV 2890429 (Pima County Super. Ct. 1994). 

Public Law 104-191, Aug. 21, 1996 Health Insurance Portability And Accountability Act Of 1996 Public 
Law, 104-191 104th Congress. 

Roark v. St. Paul Fire and Marine Ins. Co., 415 So.2d 295 (La. 1982). 

Rung v. St. Luke's Memorial Hosp. Ctr., No. 89-01825 (Oneida County Super. Ct. 1989). 

Sababin v. Superior Court (Covina Rehabilitation Center) Cal. App. 4th, 2d (2006). 

Simmons v. United States, 841 F. Supp. 748 (W. D. La. 1993). 


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References 


[1] Angoff NR. Do physicians have an ethical obligation to care for patients with AIDS? Yale J Biol Med1991;64:207-246. 


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APIC 

XnVT OF INFECTION CONTROL 
i txv I AND EPIDEMIOLOGY 


Staffing 


Author(s): Patricia W. Stone, PhD, RN 
Associate Professor 

Columbia University School of Nursing 
New York, NY 

Monika Pogorzelska-Maziarz, PhD, MPH 
Assistant Professor 

Jefferson School of Nursing 
Philadelphia, PA 

Published: October 3, 2014 


Abstract 

The role of infection preventionists has expanded as a result of the emergence of new diseases; 
changes in the healthcare delivery system, including use of new technologies and changes in 
reimbursement policies; social and political factors, such as the shortage of nurses; mandatory reporting 
of healthcare-associated infections; the need for emergency preparedness plans; and an increased 
focus on patient safety. The functions of an infection preventionist now include identification of infectious 
diseases; surveillance and epidemiological investigation; prevention and control of the transmission of 
disease; and program management, communication, research, and education. Infection preventionists 
also use their epidemiological skills to monitor and prevent noninfectious adverse outcomes related to 
patient safety. Recommended staffing levels may be outdated, necessitating the need for research on 
the appropriate staffing levels for infection prevention and control programs in the changing healthcare 
system. As the U.S. healthcare system continues to evolve, infection preventionists have an opportunity 
to participate in and lead interdisciplinary teams aimed at improving safety and quality of patient care 
efficiently by implementing evidence-based clinical practices. 

Key Concepts 

• Healthcare delivery is changing, and the infection preventionist role is expanding. 


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• Existing recommendations regarding appropriate staffing levels for infection prevention and control 
programs are outdated or incomplete. 

• Levels of bedside nurse staffing have been associated with patients' risk for healthcare-associated 
infections. 

• Reduction of healthcare-associated infections has global interest, but the staffing issues are different 
for developed and developing countries. 

• Healthcare information technology will likely affect infection preventionist workflow and staffing. 

Background 

In the past 20 years, the overall incidence of healthcare-associated infections (HAIs) has increased 36 
percent.lAnnually, in the United States, there are nearly 2 million patients stricken with HAIs, which 

translate to more than 5 percent of all hospitalized patients. Most of these infections are associated with 
the presence of an invasive device (e.g., a vascular access line, ventilator, or indwelling urinary 
catheter) or surgical procedure. 2 More than 70 percent of the bacteria that cause these infections are 

resistant to at least one of the drugs most commonly used to treat them. Nearly 100,000 of the patients 
with HAIs are estimated to die.3These estimates rank HAIs as the sixth leading cause of death in the 

United States.4,5 

In 1992, the Centers for Disease Control and Prevention (CDC) estimated the total hospital-related 
financial burden of HAIs to exceed $4.5 billion.3Using the Consumer Price Inflator, this converts to more 

than $7.5 billion in 2013 dollars. However, the original cost estimate was based on infection rates 
measured in the Study on the Efficacy of Nosocomial Infection Control (SENIC), which was conducted in 
the mid-1970s.6More recently, researchers have used matched case-control studies to estimate 

increased length of stay and hospital costs of HAIs in specific settings.3,7,8 HAIs caused by drug- 

resistant pathogens have increased costs, morbidity, and mortality.9,10 Based on the more recent 

studies, and taking into account the increased number of HAIs caused by drug-resistant pathogens, the 
CDC now estimates the annual healthcare cost of HAIs to be up to $33 billion a year .11 

The high morbidity, mortality, and costs associated with HAIs are unacceptable because a large 
proportion of HAIs are preventable. For example, 66 intensive care units (ICUs) in southwestern 
Pennsylvania formed a coalition with the goal of decreasing HAI rates.i 2 Using a multifaceted approach, 

these ICUs obtained a 68 percent decrease in central line-associated bloodstream infection rates over a 
5-year period. A similar reduction was also found in 103 ICUs in Michigan. 13 In both of these projects, 

important components of the multifaceted approach included implementation of evidence-based 
guidelines, accurate measurement of the infections, and feedback to clinicians, as well as changing the 
organizational culture to promote patient safety .14 

The Institute for Healthcare Improvement's national initiative to protect patients from 5 million incidents 
of medical harm during a span of 2 years includes specific interventions aimed at preventing surgical 
site infections, central line-associated bloodstream infections, ventilator-associated pneumonias, and 
methicillin-resistant Staphylococcus aureus (MRSA) infections. 15 These infection-related performance 


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improvement initiatives certainly include the infection preventionist (IP). Often, the IP is also involved in 
other similar quality improvement projects that are not infection related. 

As a result of the morbidity and mortality associated with HAIs and the knowledge that many are 
preventable, American consumer groups (e.g., the Committee to Reduce Infection Deaths and the 
Consumers Union) have called for mandatory public reporting of individual hospital infection rates in an 
effort to raise public awareness and motivate hospitals to make infection prevention a top priority. 
Additionally, because of the magnitude of the HAI and antibiotic resistance problem in hospitals, and the 
increasing demand for healthcare information, many states now mandate or induce hospitals to publicly 
disclose data about their performance and outcomes in relation to these infections. 

Furthermore, with the growth in healthcare spending spiraling upward and surpassing $2 trillion in 2006, 
President Bush signed the Deficit Reduction Act, which required the secretary of the Department of 
Health and Human Services to identify hospital-associated conditions (HACs) that are: (a) high cost or 
high volume or both, (b) result in the assignment of a case to a diagnosis-related group (DRG) that has 
a higher payment when present as a secondary diagnosis, and (c) could reasonably have been 
prevented through the application of evidence-based guidelines. For hospital discharges occurring on or 
after October 1, 2008, hospitals will not receive additional payment for cases in which one of the 
selected conditions was not present on admission. That is, the case would be paid as though the 
secondary diagnosis was not present and Medicare prohibits the hospital from billing the beneficiary for 
the difference between the lower and higher payment rates. Rather, the hospital is being encouraged to 
prevent an adverse event and improve the quality of care it is giving to Medicare patients. In the first 
year, 10 HACs were identified, three of which were infections (i.e., catheter-associated urinary tract 
infections [CAUTIs], vascular catheter-associated infections [VCAIs], and selected surgical site infections 
[SSIs]). Additionally, the following infections are being considered for the future: ventilator-associated 
events, S. aureus bloodstream infections, Clostridium difficile infections, and methicillin-resistant 
Staphylococcus aureus (MRSA) infections. 

In addition to the changes associated with mandatory reporting of infections, infection prevention 
activities have increased with the advent of new diseases such as acquired immune deficiency syndrome 
(AIDS), sudden acute respiratory syndrome (SARS), and avian influenza; the emergence of resistant 
strains of old diseases such as multidrug-resistant pulmonary tuberculosis; and the need for emergency 
preparedness. 16 For example, the increased number of infections caused by multidrug-resistant 

organisms has increased IPs' activity related to monitoring, safe patient placement, and assessing 
existing patient care practices. 17 IPs are also instrumental in ensuring that their facilities are in 

compliance with applicable local, state, and federal regulations, including various Occupational Safety 
and Health Administration (OSHA) requirements. is 

Other important healthcare delivery changes affecting the IP role relate to how less seriously ill patients 
increasingly receive care and services in home, community, or outpatient settings, leaving hospitals with 
a majority of "sicker" or higher acuity patients. The result is greater diversity in patient population and 
more variation in the location in which complex, invasive procedures are performed (e.g., home care, 
clinics, outpatient surgery centers) and an increasing need for IPs in these settings. These changes also 
increase the challenge of performing an essential infection prevention task in the acute care setting: 
surveillance. To develop an effective surveillance system, acute-care IPs need to incorporate the data 
limitations caused by short patient stays and patient populations with dissimilar risk factors. For 
example, developing surveillance systems and interpreting results from extended care or ambulatory 
care agencies are difficult because these patient populations may have diverse risk factors. In addition, 


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there is often an absence of diagnostic tests to aid in decision-making. Access to medical records from 
multiple care settings can be more labor intensive for the IP, and denominators may be difficult to 
establish. 

These changes in the organization and delivery of services have expanded the role of many IPs and 
expanded their required depth of knowledge. In acute care or long-term care facilities, IPs now 
increasingly operate outside of more traditional infection prevention and control programs. They may 
have responsibility for combinations of acute and nonacute healthcare facilities, such as freestanding 
surgery units, medical and dental clinics, child and adult day care centers, dialysis centers, rehabilitation 
services, and others. IPs may provide consultation on prevention and control measures for new 
diagnostic or therapeutic procedures in a variety of new care settings. 19 With increasingly complex 

technical procedures being performed in a variety of nonacute care settings, there is the potential for 
substandard sterilization and disinfection procedures when workers with limited experience and training 
perform these procedures in decentralized locations. In addition, healthcare administrators are now more 
likely to view the infection prevention and control program as part of a larger system for monitoring, 
preventing, and controlling adverse outcomes. Therefore, the duties of IPs in large healthcare systems 
may include not only infection prevention and control program activities for a single facility but also 
system-wide responsibilities for specific functions (e.g., construction, education, program management). 

In summary, the context of healthcare has changed due to many factors. As a result, the role and 
responsibilities of IPs are changing and expanding. Performance improvement is being promoted by 
providing performance feedback and tools to monitor processes, sharing lessons learned and best 
practices. The IP has a natural role in these activities; however, with the increased responsibilities and 
limited resources of many infection prevention departments, meeting these new roles may be 
challenging. 

Basic Principles 

EVIDENCE AND RECOMMENDATIONS FOR STAFFING OF INFECTION 
PREVENTION DEPARTMENTS IN ACUTE CARE SETTINGS 

In 1985, the CDC published the SENIC study. 20 SENIC provided estimates of the magnitude of HAIs 

and quantified the effects of implementing specific elements of infection prevention and control programs 
on lowering infection rates. The SENIC findings showed a reduction in HAIs with the presence of one IP 
for every 250 hospital beds and the participation of a physician knowledgeable about infection 
prevention. However, with the changes in the healthcare system, this recommendation is very dated. 

In the 1990s, participation in the CDC's National Nosocomial Infections Surveillance System (NNIS) 
required one IP full-time equivalent (FTE) for the first 100 beds and then one FTE for each additional 
250 beds. 21 Currently, the CDC's National Healthcare Safety Network (NHSN) requires a trained 

infection control professional or hospital epidemiologist to be in charge of the program. In addition, 

NHSN requires that data reporters complete online training courses related to the methods and 
definitions used in the surveillance protocols. Training materials and information about enrollment in 
NHSN can be accessed on the CDC Website at: http://www.cdc.aov/nhsn/enrollment/index.html . 

Public health codes of individual states often regulate the actual staffing of infection prevention and 
control departments. However, these regulations are often vague. For example, Connecticut's Public 
Health Code 19-13-D3 states that in short-term hospitals, 


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There shall be an individual employed by the hospital qualified by education or experience in infection 
prevention, surveillance, and control who shall conduct these aspects of the program as directed by the 
hospital infection control committee. This individual shall be directly responsible to, and be a member of, 
the infection control committee. This individual shall make a monthly report to this committee. The time 
allotted to this position shall be in accordance with current national and professional standards. 22 

The Joint Commission lists standards for infection prevention and control, which include minimizing the 
risk for development of an HAI through an organization-wide infection prevention and control program, 
identification of risk for the acquisition and transmission of infectious agents on an ongoing basis, 
effective management of the infection prevention and control program, collaboration of representatives 
from relevant components and functions within the organization in the implementation of the program, 
and allocation of adequate resources to the infection prevention and control programs. 23 However, 

there is no specific staffing requirement. 

The role of the IP and issues related to infection prevention staffing have been addressed in both 
descriptive and proscriptive publications. 24,25,26,27,28 For acute care settings, participants in the Delphi 

study 19 recommended a median of one IP for every 100 occupied beds in a 100-bed acute care 

setting. The ratio decreased slightly as the size of the facilities increased (e.g., to more than 500 beds) 
(Table 9-1). The recommendations from the Delphi study were consistent with the findings from the 
CDC's NNIS study, in which the median reported staffing is one IP for hospitals with an average daily 
census of 115 patients .21 

Several state and national surveys have been conducted in recent years to ascertain the staffing levels 
and resources available to infection prevention and control departments. As part of the Prevention of 
Nosocomial Infections and Cost Effectiveness (PNICE) study, researchers surveyed NHSN hospitals in 
2007 and 2011 to describe the state of infection prevention and control departments around the country. 
29,30 The 2007 survey of 289 hospitals found that the median staffing was one IP per 167 beds, 29 and 

these results were similar to those found in two other state surveys conducted at the same time. 31,32 

For example, in Massachusetts hospitals, the average number of beds per IP was 178, with a median of 
I66.31 

Encouragingly, the 2011 follow-up PNICE survey of almost 1,000 NHSN hospitals found higher staffing 
levels with an average number of 1.2 FTE IPs per 100 beds (standard deviation = 1.2). 30 A study 

conducted by Krein and colleagues also showed a statistically significant increase in staffing ratios from 
0.67 to 0.80 FTE IPs per 100 beds in nonfederal hospitals between 2005 and 2009, and a similar 
increase in Veterans Affairs hospitals in the same time period (0.70 to 0.88 FTE IPs per 100 beds). 33 

Table 9-1 Recommendations From a Delphi Study for Infection Preventionist Staffing by Occupied Beds 


Full-time Equivalent 

Facility Size 

Acute Care 

Setting 

Multisetting 

Long-term Care 

Median 

100 

1.0 

1.0 

0.8 


200 

1.6 

1.8 

1.1 


300 

2.5 

2.5 

2.0 


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400 

3.4 

3.0 

2.5 


500 

4.0 

3.5 

3.0 


> 500 

4.0 

3.5 

3.0 

Range 

100 

1.0 

0.3 

0.5 


200 

1.0 

1.0 

1.2 


300 

1.5 

1.7 

2.0 


400 

3.0 

3.5 

2.7 


500 

3.5 

3.5 

3.0 


> 500 

5.5 

5.5 

4.5 


From O'Boyle C, Jackson M, Henly SJ. Staffing requirements for infection control programs in US health 
care facilities: Delphi project. Am J Infect Control 2002;30:321-333. 

The PNICE researchers also found IP staffing ratio in hospitals was significantly negative related to bed 
size with smaller hospitals having higher staffing (p< .001) (Figure 9-1). 29 The negative correlation 

between IP staffing and hospital size seen in this study suggests potential economies of scale, which 
means that in larger hospitals one IP is able to provide more services. Although the researchers were 
not able to test directly for economies of scale, the variation of staffing across hospital size clearly 
illustrates the inappropriateness of assuming that a single minimum IP staffing ratio would be adequate 
across a variety of settings. In the late 1990s, publications from professional organizations for IPs, 
including the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), 
recommended that factors other than bed size be used as criteria for determining IP staffing resources. 
These factors include the complexity of care within the healthcare system, the diversity of patient 
population, and the scope of the infection prevention and control program. 34,35 Similarly, an expert 

panel on HAI prevention convened by the state of Massachusetts also recommended that staffing levels 
take into account the complexity of the patient population and the range of clinical services provided. 36 

The panel recommended staffing of 1.0 to 1.5 FTE IPs per 100 occupied beds, with institutions with 
more complex mix of cases and clinical services maintaining staffing at the higher end of the range. 


Infection Prevent ion kti (IP) Kill Time Equivalent (FTE) per 100 bedt 



Figure 9-1. 


Results from the Prevention of Nosocomial 
Infections and Cost Effectiveness (PNICE) study. 
(From Stone P, Dick A, Pogorzelska M, et al. 
Staffing and structure of infection prevention 
and control programs. Am J Infect 
Confro/2009;37(5):351-357.) 

View Image 


The current research examining the impact of 
IP staffing in infection prevention and control 
departments and availability of physicians in the 
prevention of HAI is sparse. In a systematic 
review of research examining staffing and HAI, 


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42 articles were audited. 37 In this review, the researchers found that three investigative teams 
examined the level of infection prevention staffing and patients' risk for HAI, 38,39,40 two of which found 
higher levels of infection prevention professional staffing were significantly related to lower HAI rates. 39, 

40 

Every few years the Certification Board of Infection Control (CBIC)24,4i conducts a task analysis to 

identify the activities, skills, and knowledge necessary for IPs to fill their current role. In the most recent 
analysis, CBIC found that the IP role consists of infectious disease processes, performing surveillance 
and epidemiological investigations, initiating interventions to control and prevent transmission of 
infectious agents, managing the infection prevention and control program, participating in research, 
educating healthcare personnel (HCP), and communicating to HCP and communities about infection 
prevention measures. 

In the PNICE survey described previously, the investigators found that IPs in acute care settings spent 
the largest proportion of their time collecting and analyzing data related to infections (Table 9-2). 29 This 

is similar to the results from an expert Delphi panel, from which it was estimated that 39 percent of IPs' 
time was spent on surveillance and identifying infections, 19 and a recent survey of New York IPs, who 

reported spending 45 percent of their time on surveillance. 32 Although accurate and consistent case¬ 
finding is important in reducing infections, actively working to change the organizational culture has also 
been found to be an important part of the multifaceted approach needed to promote patient safety and 
reduce infections. 12,14 It is possible that this aspect of the roles was not captured in the survey. 

Additionally, it may be possible that IPs are not yet participating in this essential activity. In the most 
recent practice analysis published by CBIC, a new activity category entitled "management and 
communication" has been identified. 42 Although it is not clear if this category fully captures the new 

roles and responsibilities, we encourage researchers in the future to assess IPs' leadership and 
involvement in teamwork and quality improvement activities aimed at the establishment of evidence- 
based clinical practices. 

Table 9-2 Activities Reported by Infection Preventionists Regarding How They Spent Their Time ( 



Percent of Time 

Mean 

SD 

Activity 

Median 

Collecting, analyzing, and interpreting data on the occurrence of infections 

49.0 

44.5 

14.3 

Policy development and meetings 

14.0 

15.0 

8.8 

Daily isolation issues 

10.0 

12.9 

9.0 

Teaching infection prevention and control policies and procedures 

10.0 

13.0 

6.2 

Other (e.g., product evaluation, employee health, and emergency preparedness) 

5.0 

8.8 

8.2 

Activities related to outbreaks 

5.0 

6.1 

4.8 


Means are the average percent of time reported by all respondents. Means do not sum to 100 percent 
due to rounding. 


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Adapted from Stone P, Dick A, Pogorzelska M, et al. Staffing and structure of infection prevention and 
control programs. Am J Infect Control 2009;37(5):351-357. 

The PNICE survey also provided information on the experience and certification of the IPs working in 
these hospital infection prevention and control programs. 29 The researchers found that 47 percent of 

the participating IPs were certified and 24 percent had less than 2 years of experience. This has 
important implications for infection prevention and suggests that reaching out to new IPs to provide 
education and role transition should be a priority. The certification process may also be important for 
these new IPs because the certification examination is designed to measure minimum competence for 
practice. In addition, recent studies have suggested a potential association between certification in 
infection control and patient outcomes. 43,44 In a recent study of California hospitals, researchers have 

found that having a certified infection control director was a significant independent predictor of lower 
multidrug-resistant organism HAI rates. 43 Furthermore, Krein and colleagues have found an association 

between the presence of a certified IP and the use of policies aimed at reducing central line-associated 
bloodstream infections. 44 

INFECTION CONTROL STAFFING IN NONACUTE CARE SETTINGS 

The delivery of healthcare in the United States has changed dramatically over the last few decades with 
an increase in services provided in nonacute settings such as skilled nursing facilities and ambulatory 
clinics. 45 To reduce the incidence of infections in nursing homes (NHs), it was mandated by the 1987 

Omnibus Reconciliation Act that each NH have an individualized infection prevention and control 
program, and it was recommended that NHs with 250 to 300 beds need a full-time IP. 46 It was also 

recommended that the IP have specific qualifications and training in epidemiology and infection control. 
While the presence of an IP to lead the infection prevention and control program is not mandated in 
NHs, the role is increasingly more common. For example, in Maryland in 2003, 8.1 percent of the NHs 
reported employing an IP; and there was a fivefold increase to 44 percent in 2008. 47 Similarly, in a 

survey of Michigan NHs, it was found that 50 percent had a full-time IP. 48 However, NH IPs are less 

likely to receive additional formal training in infection prevention and control (i.e., 8 percent compared to 
95 percent of acute care IPs) and are more likely to have additional noninfection-related 
responsibilities. 49 Better understanding of the optimal role and training of the IP in NHs is needed. 

While there are similarities between acute care and long-term care settings in the structures and 
processes needed to implement effective infection control (e.g., trained and/or certified IPs, accurate 
measurement of HAIs and processes, feedback and positive organizational climates), there are also 
important differences that impact infection control staffing and the way that infection prevention and 
control are conducted in these settings .50 

Ambulatory care centers are another setting where infection control infrastructure and resources are 
often lacking. 51 In 2010, the CDC published a guide to infection prevention in ambulatory care outlining 

the minimum expectations for safe care. 52 The key recommendations outlined for infection control in 

this setting are to: 

1. Develop and maintain infection prevention and occupational health programs. 

2. Ensure sufficient and appropriate supplies necessary for adherence to Standard Precautions (e.g., 
hand hygiene products, personal protective equipment, injection equipment). 


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3. Ensure at least one individual with training in infection prevention is employed by or regularly 
available to the facility. 

4. Develop written infection prevention policies and procedures appropriate for the services provided 
by the facility and based upon evidence-based guidelines, regulations, or standards. 52 

HOSPITAL EPIDEMIOLOGIST STAFFING AND HEALTHCARE-ASSOCIATED 
INFECTIONS 

A 2006 survey of Society for Healthcare Epidemiology of America (SHEA) members reported on the 
expanding roles of healthcare epidemiology and infection control and found varying staffing levels in 
hospital epidemiology and infection control departments with a mean number of physician FTE of 0.85 
for the smallest institutions to 1.79 FTEs for hospitals with more than 600 beds. 53 Of the members who 

responded to the survey, the vast majority (91 percent) provided hospital epidemiology services, but 
only 65 percent were specifically compensated for these services. A survey of California hospitals found 
that less than half of the hospitals reported the presence of any physician hospital epidemiologist (HE) 
with less than 4 percent of hospitals reporting the presence of a full-time HE. These findings were also 
seen in the 2011 PNICE survey that demonstrated a lack of HE in almost 50 percent of the hospitals. 30 

These data suggest that in many cases resources for hospital epidemiology are below those 
recommended in peer-reviewed literature. 

NURSE STAFFING AND HEALTHCARE-ASSOCIATED INFECTIONS 

Nurses are the largest workforce in hospitals, and although the number of nurses has grown in the last 
few years, a shortage still exists in many areas and is predicted to become worse in the coming years. 
54 Also, staff nurses have the most direct and continuous role in performing the procedures and 

interventions on which the risk for infection often hinges, making them a critical component of infection 
prevention. 

In the last 10 years, there has been much interest in gaining an understanding of the relationship 
between nurse staffing and patient safety outcomes such as HAIs. To examine these issues, research 
projects have been funded by the Agency for Healthcare Research and Quality, the National Institutes of 
Health, and the Robert Wood Johnson Foundation, as well as other agencies. A working group meeting 
of expert consultants organized in 2001 by the Division of Healthcare Quality Promotion and the CDC 
discussed available research on nurse staffing and HAIs and provided input to the CDC, nursing 
leadership, and other stakeholders on strategies for dealing with the problem of nurse staffing. 55,56 

They concluded that there is a growing evidence base examining the relationships between nurses' 
working conditions in general (with staffing included as an important aspect of working conditions) and 
patient safety outcomes such as HAIs. In an effort to bring further clarity and synthesize this evidence, 
reports have been conducted, 57,58,59 including a recently published comprehensive review specific to 

HAIs. 37 

In a comprehensive review of original studies published since 1990, 39 publications were identified in 
which the relationship between nurse staffing and HAIs in the hospital setting was examined. 37 Although 

the limitations in the study designs prevents the determination of a specific evidence-based nurse 
staffing level benchmark that is associated with decreased risk for HAI, trends are apparent from this 
research. For example, although only two investigators studied ventilator-associated pneumonia (VAP) 60 


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,61, both reported that patients being cared for in an ICU with lower levels of nurse staffing had 

increased risk for VAP. The exact mechanism for this association was not studied. Although it is possible 
that when staffing is short, the nurses are unable to provide recommended care such as keeping the 
patient's head of bed elevated. 62 Burnout is another potential explanation for the association seen 

between patient-to-nurse ratios and urinary tract and surgical site infections as reported by a recent 
study conducted by Cimiotti and colleagues. 63 Furthermore, researchers studying organism-specific HAI 

using single-site designs all found the level and/or the use of nonpermanent staff significantly related to 
a patient's infection risk. The notion that being cared for by float nurses versus full-time permanent staff 
nurses in ICUs could put a patient at risk for HAI may seem surprising. However, it is in keeping with 
Pronovost's description of ICU work environments and how important it is to have good communication 
channels with strong interdisciplinary teamwork. 64 Temporary staff may lack specific training and 

familiarity with institutional procedures and "best practices" for preventing HAIs. Hospital administrators, 
nurse managers, and IPs should be aware of the importance of interdisciplinary teamwork and the need 
for both consistent training and adequate nurse staffing in reducing HAIs. 

SUMMARY 

In summary, the existing recommendations regarding appropriate staffing levels for infection prevention 
and control programs are outdated or incomplete. Many recommendations were made before the 
reorganization of healthcare delivery and the new functional demands on IPs. The critical staffing 
challenge for IPs is to identify those activities that are essential to the infection prevention and control 
program and to quantify the time and resources necessary to accomplish those activities. More research 
is needed to address methods by which IPs can fully integrate their expanded responsibilities (i.e., 
across the healthcare continuum) into meaningful cost-effective infection prevention and control 
programs. Periodic assessments of the needs, resources, and strengths of the infection prevention and 
control program can help clarify the program's goals and activities and help it better reflect the mission 
of the larger healthcare organization. 

Future Trends 

Healthcare information technology is expanding in all sectors. Information and informatics infrastructure 
are critical to the IP role. There is considerable promise related to electronic healthcare records and 
improving adherence to guidelines and improving the workflow of IPs through electronic surveillance or 
other data mining techniques. For example, the implementation of some interventions such as computer 
reminders for removal of catheters (both urinary and central line) and computerized antibiotic 
stewardship protocols may be helpful in decreasing infections. However, it is clear that electronic 
surveillance is not adequate. 65,66 It is not reasonable to believe that electronic surveillance without 

expert clinician oversight would ever become the standard for infection prevention. However, it is likely 
that healthcare information technologies will become increasingly used by IPs. It is also important to 
realize that implementation of new technologies is complex and often difficult. Indeed, with initial 
implementation of some technologies, there are often unintended consequences such as increased 
workload. 67 Understanding how these tools transform the role of the IP and establishing best practices 

will be important. 

International Perspective 


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Patient safety and reduction of HAIs is gaining global interest. 68 Internationally, though, the issues 
regarding staffing are different for the developed and developing countries. 

ISSUES FOR DEVELOPED COUNTRIES 

The Antimicrobial Resistance Prevention and Control (ARPAC) study was conducted to ascertain the 
organization and policies of infection prevention and control programs in 169 acute care hospitals in 32 
countries in Europe in 2 001. 69 Of the hospitals in this study, 72 percent reported a formal infection 

prevention program and 90 percent reported the existence of a multidisciplinary infection prevention 
committee. The presence of infection prevention nurses was reported in 80 percent of the hospitals and 
varied by geographical region (100 percent in northern Europe to 54 percent in southeastern and 
central eastern Europe). The median staffing levels reported in the study were 2.33 infection prevention 
nurses per 1,000 beds and 0.94 infection prevention doctors. 70 Moreover, only 18 percent of the 

hospitals reported more than one infection prevention nurse per 250 beds and 69 percent of the 
hospitals reported lack of skilled staff as one of the problems in implementing infection control policies. 
These results show that staffing levels for infection prevention nurses are below recommended staffing 
standards. For example, the European Study Group on Nosocomial Infections estimated staffing 
requirements to be 1.8 infection prevention doctors and 4.2 infection prevention nurses per 1,000 beds, 
with an additional 3.3 personnel per 1,000 beds available for data management and administrative 
support. Similarly, a group of IPs and medical microbiologists convened in the Netherlands in 2007 
determined that a minimum staffing of one IP FTE per 178 medical beds or one IP FTE per 5,000 
admissions was needed to carry out infection control activities in acute care settings. 71 On a hopeful 

note, the median staffing levels reported in the ARPAC study are higher than the median ratios reported 
5 years earlier in European hospitals. 40 Moreover, the ARPAC study results were discussed at the 2004 

Consensus Conference, leading to development of recommendations that included ensuring that acute 
care hospitals have adequate infection prevention staffing, with the SENIC recommendations considered 
the minimum, establishing certified training in infection prevention, and removing barriers to the 
successful implementation of infection policies such as lack of isolation rooms and skilled staff, n In 

many European countries, infection prevention training is not formally certified as a medical specialty 
and may therefore vary widely. 70 This lack of standardization has been noted by the European Society 

of Clinical Microbiology and Infectious Diseases, which has published recommendations for training 
programs in infection prevention. 73 

The use of an infection prevention "link" nurse, which is defined as a nurse working on the ward who 
liaises with the infection prevention department, 74 is seen increasingly in European countries. For 

example, the ARPAC study shows that more than 46 percent of the study hospitals reported the 
presence of a link nurse. 69 The main role of link nurses is to "provide information to assist in the early 

detection of outbreaks of infection and to help increase awareness of infection prevention issues in their 
ward." 74 By being directly based in the wards and providing direct patient care, link nurses can help the 

wards to develop ownership of infection prevention and serve as a resource to their colleagues. 74 

Several studies have shown the value of link nurses in influencing infection prevention practices at the 
ward level, 75 their usefulness in facilitating the collection of HAI data, 76 and their ability to provide 

education and help in the implementation of policies at the ward level. 11 Although the value of link 

nurses has been shown in many settings, operational difficulties such as high staff turnover and need 


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for sustained monitoring and support of the link program have been reported and necessitate further 
investigation. 74 

ISSUES FOR DEVELOPING COUNTRIES 

The problems associated with reduction in HAIs and successful implementation of infection prevention 
and control programs are even more pronounced in developing countries. A recent report from the 
International Nosocomial Infection Control Consortium (INICC) indicates that rates of device-associated 
HAI are much higher in INICC ICUs compared to U.S. ICUs participating in the NHSN, even though use 
of devices is similar. 78 Some of the factors that are thought to play a role in these increased rates are 

the scarce financial and administrative resources available for infection prevention in the majority of 
hospitals in developing countries, lack of laws directing the establishment of infection prevention and 
control programs, low nurse staffing ratios, and low compliance with hand hygiene guidelines. 79 , 80,81 

Another problem that affects the health systems in developing countries is the migration of HCP within 
and between countries because of the increased demand in developed countries. More study is required 
to adequately assess this trend and to develop appropriate public policy responses .81 


Conclusions 

There is not a set staffing ratio that is effective across multiple settings. It is clear that the role of the IP 
is changing, but it is not clear whether sufficient resources are being allocated to staffing. Monitoring the 
changing role of the IP in light of the changing healthcare delivery system and making efforts to 
determine what constitutes sufficient staffing will continue to be important and is an area for needed 
research. 

Supplemental Resources 

Soule BM. The evolution of our profession: lessons from Darwin. Tenth annual Carole DeMille lecture. 
Am J Infect Control 1991;19:45-59. 

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[61] Stone PW, Mooney-Kane C, Larson EL, et al. Nurse working conditions and patient safety outcomes. Med Care 
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[62] Resar R, Pronovost P, Haraden C, et al. Using a bundle approach to improve ventilator care processes and reduce 
ventilator-associated pneumonia. Jt Comm J Qual Patient Saf 2005;31:243-248. 

[63] Cimiotti JP, Aiken LH, Sloane DM, et al. Nurse staffing, burnout and health-care associated infections. Am J Infect 
Control 2012;40:486-490. 

[64] Gawande A. The checklist. The New Yorker, December 10, 2007. 

[65] Chandra PN, Milind K. Lapses in measures recommended for preventing hospital-acquired infection. J Hosp Infect 
2001;47:218-222. 

[66] Diallo K. Data on the migration of health-care workers: sources, uses, and challenges. Bull World Health Organ 
2004;82:601-607. 

[67] Stone P, Horan T, Huai-Che S, et al. Comparisons of healthcare associated infections using two different 
mechanisms for public reporting. Am J Infect Control 2007;35:145-149. 

[68] Donaldson LJ, Fletcher MG. The WHO World Alliance for Patient Safety: towards the years of living less 
dangerously. Med J Aust 2006; 184(suppl 10):S69-S72. 

[69] Struelens MJ, Wagner D, Bruce J, et al. Status of infection control policies and organisation in European hospitals, 
2001: the ARPAC study. Clin Microbiol Infect 2006;12:729-737. 

[70] Voss A, Allerberger F, Bouza E, et al. The training curriculum in hospital infection control. Clin Microbiol Infect 
2005;11(suppl 1):33-35. 

[71] Van der Broek PJ, Kluytmans JAJW, Ummels LC, et al. How any infection control staff do we need in hospitals? J 
Hosp Infect 2007;65:108-111. 

[72] MacKenzie FM, Struelens MJ, Towner KJ, et al. Report of the Consensus Conference on Antibiotic Resistance, 
Prevention and Control (ARPAC). Clin Microbiol Infect 2005;11:938-954. 

[73] Norrby SR, Carbon C. Report of working group 3: specialist training and continuing medical education/professional 
development in the infection disciplines. Clin Microbiol Infect 2005;11(suppl 1):46^t9. 

[74] Dawson SJ. The role of the infection control link nurse. J Hosp Infect 2003;54:251-257. 

[75] Millward S, Barnett J, Thomlinson D. A clinical infection control audit programme: evaluation of an audit tool used by 
infection control nurses to monitor standards and assess effective staff training. J Hosp Infect 1993;24:219-232. 

[76] Teare EL, Peacock A. The development of an infection control link-nurse programme in a district general hospital. J 
Hosp Infect 1996;34:267-278. 

[77] Ching TY, Seto WH. Evaluating the efficacy of the infection control liaison nurse in the hospital. J Adv Nurs 
1990;15:1128-1131. 

[78] Rosenthal VD, Maki DG, Mehta A, et al. International Nosocomial Infection Control Consortium report, data summary 
for 2002-2007, issued January 2008. Am J Infect Control 2008;36:627-637. 

[79] Rezende EM, Couto BR, Starling CE, et al. Prevalence of nosocomial infections in general hospitals in Belo 
Horizonte. Infect Control Hosp Epidemiol 1998;19:872-876. 

[80] Stevenson KB, Khan Y, Dickman J, et al. Administrative coding data, compared with CDC/NHSN criteria, are poor 
indicators of health care-associated infections. Am J Infect Control 2008;36:155-164. 


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Section 2 

Epidemiology, Surveillance, Performance, 
and Patient Safety Measures 



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APIC 

XrVT OF INFECTION CONTROL 
! txv I AND EPIDEMIOLOGY 


General Principles of Epidemiology 


Author(s): Samantha M. Tweeten, PhD, MPH 
Epidemiologist 

Epidemiology and Immunization Services Branch 
Health and Human Services Agency 
County of San Diego 
San Diego, CA 

Published: February 25 , 2016 


Abstract 

Epidemiology—the study of the frequency, distribution, cause, and control of disease in populations — 
forms the basis of all health-related studies. It provides the background for interventions to reduce 
transmission of infecting organisms, reduce the number of healthcare-associated infections, and protect 
healthcare providers from infection. Understanding the relationships of host, environment, and organism 
will aid the infection preventionist in designing studies to determine the cause of healthcare-associated 
infections and design interventions. 

Key Concepts 

• The primary purpose of epidemiology is to aid in the understanding of the cause of a disease by 
knowing its distribution; determinants in terms of person, place, and time; and natural history. 

• Understanding the elements involved in the transmission of infection enables infection preventionists 
to develop strategies that target specific areas in the process. 

• Selecting the appropriate study design is an essential step in answering questions important to the 
infection preventionist. 

• The infection preventionist should understand the meaning of commonly used terms and know how to 
apply basic epidemiology skills. 

• Correct presentation of data allows the infection preventionist to demonstrate outcomes and 
relationships in a manner that will likely encourage collaboration and support among stakeholders. 


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Background 

This chapter provides information about the epidemiological principles and methods used in the practice 
of infection surveillance, prevention, and control and shows that they are an important part of the 
discipline known as epidemiology. 

The infectious disease process is a set of complex interrelationships of agent, host, and environment 
that has been studied by epidemiologists for more than a century. One goal of epidemiology is to 
understand the natural history of diseases and conditions to develop strategies for their prevention and 
control. Three closely interrelated components—distribution, determinants, and frequency—are integral 
to the principles and methods of epidemiology. By becoming familiar with these concepts, the infection 
preventionist (IP) will begin to develop and expand a knowledge base for interpreting data gathered 
within and outside the healthcare facility and for understanding the associations between risk factors 
and infection in different settings and how these findings can be used to reduce infection risks for 
patients and healthcare personnel (HCP). The Supplemental Resources cited at the end of this chapter 
reflect the breadth and depth of the discipline. 

Epidemiology as a discipline incorporates the use of statistics to determine associations and test 
hypotheses. Examples used to explain formulas and calculations are drawn from familiar settings, yet 
the IP with little or no background in statistics is not expected to master the materials in this chapter 
without additional study. An expanded discussion about the statistics used in epidemiology is beyond the 
scope of this chapter. 

Although information is provided about the theoretical basis for epidemiology and statistics, the principal 
goal of this chapter is to present practical information that will allow the IP to use epidemiological skills 
in day-to-day practice. Following completion of this chapter, the reader will have a better understanding 
of healthcare-associated infections (HAIs) within the total discipline of epidemiology and how principles 
of epidemiology can be applied to many practice issues. 

Basic Principles 

Epidemiology is the study of the distribution and determinants of disease and other conditions in human 
populations—both a body of knowledge and a method of study. Epidemiology encompasses the study of 
many factors that are detrimental to human health, including infectious diseases, chronic diseases such 
as cancer or heart disease, drug or alcohol abuse and their sequelae, violence, injury, and others. 

Epidemiology, unlike clinical medicine, is population-based and is useful for describing health-related 
phenomena in groups of people. Epidemiological methods are used in the measurement of a disease, 
its determinants, and its distribution in a particular population in question before, during, and after an 
intervention. Therefore, epidemiology can be used in determining whether there is a problem in a 
population, risk factors for a disease, and whether there has been a change in disease outcome after 
an intervention. Although epidemiology studies groups of people rather than an individual patient, its 
principles are used widely in all areas of healthcare. Epidemiology provides information for community 
and preventive medicine, analysis of health assessments, safety programs, utilization review and 
management of resources, and health planning and forecasting. As an applied science, epidemiology is 
a professional discipline that encompasses all academic fields of study. 

The primary purpose of epidemiology is to aid in the understanding of the cause of a disease by 
knowing its distribution; determinants in terms of person, place, and time; and natural history. This 


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information is also used in epidemiology to plan and evaluate interventions and prevention efforts more 
effectively. To this end, several approaches, or methodologies, are used in obtaining epidemiological 
information. These include observational studies, in which the natural course of events is observed, and 
experimental studies, in which the investigator actively intervenes to modify one or more factors. 
Observational studies may be either descriptive, in which events are described in terms of person, 
place, or time, or analytical, in which risk factors and trends are observed and compared. These 
methodologies are described in greater detail later. 

To understand the interactions between risk factors and the development of disease, it is first important 
to understand the elements that cause disease. The "epidemiological triangle" model of disease (see 
Figure 10-1) consists of three elements: host, agent, and environment. The host is the human, whereas 
the environment consists of all external factors associated with the host. The agent may be a bacteria, 
virus, fungus, protozoan, helminth, or prion. In this model of dynamic interaction, change in any 
component alters the existing equilibrium. Change may increase or decrease the frequency of disease. 
Although this model is particularly useful in the study of infectious diseases, it is also applicable to other 
conditions. 


Host 


Figure 10-1. 

Epidemiologic triangle model of disease 
causation. 

View Image 

The "wheel" model (see Figure 10-2) consists of 
a hub (the host or human) with an inner core of 
genetic information. The environment 
surrounding the host is divided into three parts: 
physical, biological, and social. The size of each 
component is related to the disease process 
under consideration. For example, the genetic 
core is large for hereditary disease and small 
for childhood viral diseases. The emphasis in 

this model is not the agent per se but on the interaction between the host and the environment and the 
agent and the environment. 


Agent 



Environment 



Social 

environment 


Genetic 

core 


Physical 

environment 


Figure 10-2. 

"Wheel" model of disease causa"... „ _ 

View Image lnl 

A third model for describing how disease occurs 
is the "web of causation" (see Figure 10-3). In 
this model there is an attempt to capture the 
more complex interactions between the 
biological (host), environmental, and social 
factors that contribute to disease. There is 
emphasis on the contributions of social and 
political aspects of human life and how these 
are interrelated to other contributing factors. 


Figure 10-3. 

"Web" model of disease causation. ... , , 

View Image M 


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ASSOCIATION AND CAUSATION 

Association occurs if, as one variable changes, 
there is a concomitant or resultant change in 
the quantity or quality of another variable. When 
a statistical association between a factor and a 
disease has been demonstrated, it may be of 
three types: artifactual (or spurious), indirect or 
noncausal, or causal. A certain number of 
associations will simply occur by chance, with 
the number of associations rising as a greater 
number of factors or variables are studied. This 
is known as random error. Artifactual 
associations may also be caused by errors in 
study design or analysis, leading to the introduction of systematic error or bias. Bias in study design 
may be caused by instrument, observer, data collection method, case and control group selection 
(selection bias resulting in subject groups not being comparable), or other errors. Errors in analysis, 
including inappropriate choice of statistical test and underpowering of studies, may lead to bias. Failure 
to control for confounding variables in the study design or analysis may also result in artifactual 
associations. Bias and random error may also result in no association being seen when one actually 
exists. 

Indirect or noncausal associations may result from the mixing of effects between the exposure, the 
disease, and a third factor, or confounding variable, that may be associated with the exposure and 
independently affect the outcome of interest. Confounding can lead to the assumption that there are 
differences that do not really exist or to the observation that there is no difference when one truly 
exists. Causal associations exist when evidence indicates that one factor is clearly shown to increase 
the probability of the occurrence of a disease. In a causal relationship, the reduction, or diminution, of a 
factor decreases the frequency of the disease being studied. This should not be confused with causality, 
which requires a number of conditions to be met, one of which is the presence of causal associations. 

The scientific criteria for disease causation have their roots in Koch's postulates (Robert Koch, 1843- 
1910). Koch's postulates consist of four points: 

1. The organism must always be found with the disease, in accordance with the clinical stage 
observed. 

2. The organism must then be grown in pure culture from a diseased host. 

3. The same disease must be reproduced when a pure culture of the organism is inoculated into a 
healthy susceptible host. 

4. The organism must then be recovered from the experimentally infected host. 

These postulates were originally accepted as an attempt to establish a causal relationship between 
microorganisms and disease processes. Although historically significant, as we have learned more about 
disease causation, it has become apparent that Koch's postulates cannot always be fulfilled (e.g., 
multicausal diseases, chronic diseases, some viral diseases). Koch himself accepted that not all of his 
criteria would be met in each case. 

The currently used criteria for causality were developed by Austin Bradford Hill (1897-1991) and are 
known as Hill's criteria. These criteria use modern epidemiological methods to determine whether a 



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factor is causal for a given disease and are listed in Table 10-1. These criteria are equally applicable to 
infectious and noninfectious diseases. 

1. Strength of association. The incidence of disease should be higher in those who are exposed to 
the factor under consideration than in those who are not exposed; that is, the stronger the 
association between an exposure and a disease, the more likely the exposure is to be causal. For 
example, lung cancer is common in those who smoke. 

2. Consistency means that the association should be observed in numerous studies, preferably by 
different researchers using different research methodologies. 

3. Specificity refers to an association between one factor and one disease, and this association is 
more likely to be causal. This criterion also refers to the extent to which the occurrence of one 
factor can be used to predict the occurrence of another (disease). In reality, such a one-to-one 
relationship is rare due to the multifactorial causes of most diseases and because, sometimes, the 
same factor(s) can cause more than one disease. 

4. Temporalitymust also be addressed when determining cause of disease. Essentially, exposure to 
the hypothesized causal factor must precede the onset of disease. 

5. The biological gradient is a dose-response relationship between increased exposure to a factor 
and increased likelihood of disease. For example, the longer one smokes, the more likely one is 
to develop lung cancer. If the association demonstrates a biological gradient between the factor 
(exposure) and effect (disease), the relationship is more likely to be causal. 

6 . The association in question should also be biologically plausible in light of current knowledge. This 
criterion may be the most elusive and variable of the nine. Because biological knowledge is ever 
expanding, lack of biological plausibility does not necessarily disprove a theoretical association. 

7. There should be coherence between known information about the biological spectrum of the 
disease and the associated factor; that is, the association should be in accordance with other 
facts known about the natural history of the disease. 

8 . Associations derived from experiments add considerable weight to evidence supporting causal 
associations. These experiments can be animal model studies or clinical trials; however, although 
animal models may be helpful, many diseases do not manifest the same way in animals and 
humans. 

9. Finally, if similar associations have been shown to be causal, by analogy the association is more 
likely to be causal. Determining causality may also help to determine at which points the natural 
history of a disease may be interrupted, so that prevention and control efforts are effective. It can 
also add information on the natural history of a disease. 

Table 10-1 Table 10-1. Hill’s Criteria for Causation 

Strength 

Consistency 

Specificity 

Temporality 

Biological gradient 

Plausibility 

Coherence 

Experiment 


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Analogy 


The association between Shigella sonnei and gastroenteritis provides an example of applying Hill's 
criteria to an infectious disease. Strength is demonstrated by disease occurrence among those exposed 
to the organism. The association between ingestion of S. sonnei and gastroenteritis has been 
demonstrated consistently in numerous studies by different investigators, although development of 
disease may not occur 100 percent of the time. Temporality is demonstrated because exposure to the 
organism precedes development of gastroenteritis and occurs within the correct incubation period. The 
biological gradient is evident because larger doses of S. sonnei are more likely to result in disease. S. 
sonnei is a biologically plausible cause of gastroenteritis, based on knowledge of its toxin production, 
and disease caused by S. sonnei is coherent with other facts known about gastroenteritis. In addition, 
experiments have shown that S. sonnei causes gastroenteritis and that other species of Shigella cause, 
analogously, similar disease. All this leads to the conclusion that there is a causal association between 
S. sonnei and gastroenteritis. 

Applying the criteria for causality is not as straightforward when the etiology is not clear. The 
associations between toxic shock syndrome (TSS), Staphylococcus aureus, and tampon use pose such 
a problem. There is increased risk of disease in females who use tampons (strength), and most studies 
(consistency) have shown a relationship between S. aureus and TSS. Although other organisms can 
cause TSS, in no case has TSS associated with tampon use been associated with any other organism 
(specificity). However, in the initial stages of the investigation, the role of many other vaginal organisms 
was studied. The presence of S. aureus alone or tampons alone does not cause disease; a number of 
other factors are involved. No specific phage has been found that induces the production of the toxin 
implicated in TSS associated with tampon use. Colonization with S. aureus probably precedes TSS 
disease and also cases of TSS in patients with postoperative wounds (temporality). It is postulated that 
continuous, more than intermittent (biological gradient), use of superabsorbent tampons allows a large 
number of organisms to persist in the vaginal canal. Plausibility and coherence is demonstrated by the 
knowledge that some S. aureus strains produce toxins that can cause toxic poisoning and a shock 
syndrome. Experiments with S. aureus toxins have shown that these toxins produce disease. TSS is 
consistent with a toxin-induced illness, and the disease is consistent with our knowledge of S. 
aureus diseases, such as staphylococcal food poisoning and scalded skin syndrome, both of which are 
caused by S. aureus toxins (analogy). Based on Hill's criteria, the conclusion reached is that a causal 
association exists between S. aureus and TSS; however, a simple causal relationship does not exist 
between superabsorbent tampons and TSS. Superabsorbent tampons are one of many risk factors for 
TSS. 

There are difficulties associated with the use of criteria for causality. Although certain study designs 
(e.g., random-allocation clinical trials) produce data that are used to prove causality, in fact, even with 
all criteria met, it is rarely possible to explain all the factors contributing to a specific disease entity. For 
example, tuberculosis has been classically viewed as meeting all of the criteria to satisfy Koch's 
postulates. Yet recent approaches to the study of this disease clearly indicate that socialization and 
lifestyle, and coinfection with human immunodeficiency virus (HIV), have an impact on the risk for 
development of tuberculosis. In addition, if a well-described disease with a clearly defined etiological 
agent is subject to a "third cause" (i.e., an unmeasurable factor), it follows that diseases that are less 
well described or lack clearly defined etiological agents will frequently be subjected to challenges about 
undetermined contributing factors. An example is the challenge to the causal association of smoking and 
lung cancer. The tobacco industry maintains that the association between smoking and lung cancer is 
the result of some yet to be defined variable and that the association with smoking is only a spurious 
result. The tobacco industry uses the argument that not all people who develop lung cancer are 


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smokers. (However, epidemiological research and analyses of many studies by Doll and Peto have 
demonstrated that smoking meets Hill's criteria for causality of lung cancer and a number of other 
diseases.) 

Uses of Epidemology in Healthcare 

One of the uses of epidemiology is to apply information gathered to various forms of disease 
prevention. There are three categories of prevention, which are sometimes referred to as Leavell's 
levels: primary, secondary, and tertiary. Primary prevention includes health promotion programs, such as 
wellness programs, and specific protections, such as immunization. The goal is the complete prevention 
of a disease before any manifestation of that disease occurs, preferably before the occurrence of any 
preclinical changes that may lead to disease. Secondary prevention refers to early diagnosis and 
treatment and includes skin testing in tuberculosis and mammograms for early detection of breast 
cancer. Secondary prevention also involves methods that may limit disability, such as stopping smoking 
in people with chronic bronchitis. The emphasis is on preventing further deterioration by intervention as 
early in the disease course as possible. Tertiary prevention occurs after disease is well established and 
deals with sequelae of disease. Examples of tertiary prevention include rehabilitation and organ 
transplantation. 

Applications of disease prevention, using information gathered with epidemiological studies, are wide- 
ranging. Prevention efforts occur in community and healthcare facility-based healthcare delivery systems. 
Forecasting for future needs in both treating illness and promoting health is important in healthcare 
planning. Prevention forms a part of occupational and environmental programs in the workplace, the 
ambient environment, and in the reduction of workers' risks. Noninfectious events, both acute (e.g., auto 
accidents, poisonings) and chronic (e.g., heart diseases, malignant neoplasms), have been the target of 
many prevention programs. 

Prevention programs also have a place in infectious diseases. Some acute infections with the potential 
for spread into the community, such as measles, rubella or other childhood diseases, are addressed 
with vaccine programs. Infections that may become chronic, such as tuberculosis, are prevented by 
limiting exposure to those who are contagious and by treatment of those who have active disease. 
Prevention of HAIs requires intensive staff education. It is also important to understand the stages of the 
natural history of disease and the relationship to primary, secondary, and tertiary levels of prevention 
(see Figure 10-4). Decisions about prevention will, in part, be dependent on the stage of a given 
disease at which interventions can be made. Ideally, primary prevention should be carried out, but this 
is not necessarily practical or possible. 



Figure 10-4. 


Stages of the natural history of a condition and 

their relationship to primary, secondary, and 

tertiary prevention. (Redrawn from Clark MJ. 

Nursing in the Community. Norwalk, CT: 

Appleton & Lange, 1992.) 

^ a > / View Image 


Prevention strategies in healthcare infection 
prevention are wide-ranging and depend on the 
disease in question and what information is 
available to the practitioner. Prevention 


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strategies to reduce the risk of transmission—including barrier precautions, immunizations of HCP, and 
cleaning, sterilizing, and disinfecting—are designed to prevent the occurrence of disease and, therefore, 
form primary prevention measures. Forecasting for future health needs as the general population ages 
must lead to infection prevention practices that deal with health problems of the elderly. Occupational 
and environmental health exposures may be prevented in hospital personnel through programs and 
training, such as the use of barrier methods to prevent transmission of bloodborne pathogens or 
appropriate barriers to prevent tuberculosis transmission. Prevention of HAIs also requires an 
understanding of the impact that chronic diseases and underlying conditions (e.g., immunosuppression, 
chronic obstructive pulmonary disease) have on increasing the risk of HAIs. 

USEFUL TERMS IN INFECTIOUS DISEASE EPIDEMIOLOGY 

A basic knowledge of terminology used in infectious disease epidemiology makes both understanding 
and communication easier. Listed here are a number of terms and their definitions that will be useful to 
the infection preventionist. 

Incidence: the number of new cases of a given disease in a given time period. For example, the 
number of newly diagnosed cases of active tuberculosis in a calendar year in a given county is the 
incidence of tuberculosis in that county. 

Prevalence: the number of existent cases of a given disease at a given time. For example, the number 
of active tuberculosis cases in the same county at the midpoint of the calendar year. 

Endemic: the usual incidence of a given disease within a geographical area during a specified time 
period. 

Epidemic: an excess over the expected incidence of disease within a given geographical area during a 
specified time period. If the expected number of cases of a disease in a county is 8 per year, and 16 
occur in 1 year, this indicates an epidemic. It should be noted that an epidemic is not defined on the 
absolute number of cases but on the number of cases in comparison to what is expected. 

Pandemic: an epidemic spread over a wide geographical area, across countries or continents. 

Outbreak: synonymous with epidemic but a term often preferred when dealing with the public. It may not 
evoke the same fearful response as the term epidemic. 

Enzootic: the usual presence of disease among animals within a geographical area. The animals may 
serve as a reservoir for a zoonotic disease. 

Epizootic: an excess over the expected extent of disease within an animal population in a geographical 
area during a specified time period. 

Zoonosis: a disease transmitted from animals to humans (e.g., cat scratch fever, psittacosis). 

Reservoir: place in which an infectious agent can survive but may or may not multiply, for example, 
Pseudomonas'm nebulizers and Hepatitis B on the surface of a hemodialysis machine. HCP may also be 
reservoirs for a number of HAI organisms. 

Fomite: an inanimate object on which organisms may exist for some period of time. For example, the 
hemodialysis machine in the previous example. 

Herd immunity: the resistance of a group to invasion and to spread of an infectious agent, based on the 
immunity of a high proportion of individual members of the group. 


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Risk: the probability or likelihood of an event occurring. 

Risk factor: a characteristic, behavior, or experience that increases the probability of developing a 
negative health status (e.g., disease, infection). 


Infection is the entry into and multiplication of an infectious agent in the tissues of the host and tissue 
damage resulting in apparent or unapparent changes in the host (see Figure 10-5). Unapparent, 
asymptomatic, or subclinical infections run a course similar to that of clinical disease but below the 
threshold of discernible clinical symptoms. Apparent, clinical, or symptomatic infections result in clinical 
signs and symptoms of a recognizable disease process. 


Symptoms and (onitihrtionol raachont 



Figure 10-5. 

Infectious disease spectrum: various host 

responses to infection by an infectious agent. 

(Redrawn from Centers for Disease Control and 

Prevention. Principles of Disease Control—A 

Three-Day Training Course. Atlanta, GA: CDC, 

1992). w , 

View Image li^l 


HAIs are those that are not present at the time 
of admission to the hospital but are temporally associated with admission to or a procedure performed 
in a healthcare facility. An infection present at the time of admission may also be healthcare-associated 
if it is related to a recent hospitalization. Sometimes it is difficult to determine if an infection is 
healthcare-associated, particularly if information on previous hospitalizations is not available. In contrast 
to HAIs are community-acquired infections, those infections present on admission with no association to 
a recent hospitalization. 


In addition to understanding the concepts of healthcare-associated and community-acquired infection, it 
is important that the IP understands the concept of colonization. Colonization is the presence of 
microorganisms in or on a host with growth and multiplication but without tissue invasion or damage. A 
thorough understanding of this concept is essential in the planning and implantation of epidemiological 
studies in a healthcare infection prevention and control program. Confusing colonization with infection 
can lead to spurious associations that may lead to expensive, ineffective, and time-consuming 
interventions. However, the IP must also realize that colonization may become infection when changes in 
the host occur and that, for some disease entities, a colonized host may spread organisms to other 
patients. 


THE CHAIN OF INFECTION 

The infection process can be described as a chain of infection (see Figure 10-6). Understanding this 
chain must precede the breaking of its links, which leads to prevention of infection. Each component, or 
link, in this chain is connected to another link in the chain. 

The causative agent of infection can be thought of as the first link in the chain. A causative agent is a 
biological, physical, or chemical entity capable of causing disease. Biological agents may be bacteria, 
viruses, fungi, protozoa, helminths, or prions. Some biological agents have characteristics that make 
them more successful in causing infection. To cause disease, these agents must be invasive enough to 
enter tissues, multiply, and cause some amount of damage. They must be sufficiently virulent to be 
pathogenic. The infectious dose (the number of organisms required to cause disease) and how viable 
an organism is in the free state also determines whether infection will develop. Host specificity affects 


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organism success as well. An organism causing disease only in marmosets probably will not have 
success in causing infection in humans. 

Organisms may also have high rates of antigenic variation that help to circumvent host-immune 
responses. This is the case with influenza, in which the outer protein antigens change from year to year, 
necessitating the yearly development of a new influenza vaccine. The ability to develop antimicrobial 
resistance also provides the organism with an advantage to continue causing infection, despite what was 
previously appropriate treatment. 


Figure 10-6. 

The chain of infection. Components of the 

infectious disease process. ... . „ 

View Image IUI 

The next link in the chain is the reservoir—that 
is, a place in which an infectious agent can 
survive but may or may not multiply. There are 
three common reservoirs of interest: humans, 
animals, and environment. Common reservoirs 
associated with HAIs include patients, HCP, and 
healthcare equipment and environment. Human 
reservoirs are generally cases with the disease 
in question, either acute clinical cases or 
subclinical (asymptomatic) cases, or carriers. A 
carrier is a person who shows no recognizable 
signs or symptoms of a disease but is capable 
of spreading disease to others, such as HCP 
with methicillin-resistant Staphylococcus 
aureus (MRSA) nasal colonization. During the 
prodromal phase of some diseases, the 
organism is multiplying but has not yet caused signs and symptoms of the disease and may be 
transmitted to others. Convalescent carriers are those who have recovered from the disease but still 
have organisms present that can be transmitted. For example, a patient with cholera may continue to 
shed bacteria in the stool for several weeks after diarrhea has subsided. Chronic or sustained carriers 
may continue to have organisms present for very long periods of time. "Typhoid" Mary Malone is an 
example of a chronic carrier; Salmonella typhi may continue to exist in the gallbladder of a significant 
number of people who have recovered from typhoid. From the gallbladder, it is shed through the 
gastrointestinal tract and may infect those who come in contact with the carrier's feces. Carriers can live 
long and healthy lives with the organism present. There are also intermittent carriers who periodically 
shed organisms, such as S. aureus. Subclinical cases and carriers present a particular risk of 
transmission to susceptible hosts in the healthcare setting because they are less likely to be recognized. 
There may be no indication that they are ill or that they may be infectious. Precautionary measures to 
prevent transmission are less likely to be instituted because illness is not apparent. 

The next link in the chain of infection is the portal of exit—that is, the path by which an infectious agent 
leaves the reservoir. Portals of exit and portals of entry are listed in Table 10-2. 

The mode of transmission, the next link in the chain of infection, is the method by which the organism 
reaches a susceptible host. Contact transmission is of particular importance in the healthcare setting. 

Direct contact is person-to-person spread with actual physical contact occurring between a source and a 



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susceptible host (e.g., fecal-oral spread of Hepatitis A virus). Indirect contact may occur when a patient 
comes in contact with a contaminated intermediate object or fomite. An example in the healthcare 
setting would be a bed rail contaminated with small particles of stool. Some organisms, such as MRSA 
or vancomycin-resistant enterococci (VRE), may survive for days or weeks in the environment and be 
available for direct or indirect contact transmission. Droplet transmission occurs when the infectious 
agent spends only a brief period passing through air and can be inhaled at that time. Droplets may 
arise from speaking, coughing, or sneezing. Because heavy droplets travel only a short distance, 
generally a meter (about 3 feet) or less, the infected person and susceptible host need to be relatively 
close to each other for efficient transmission to occur. 

Common vehicles, such as food and water, may also transmit infectious agents. In active direct 
transmission with a common source, the organism first replicates in the vehicle, producing a larger dose 
of the organism, which is then ingested, such as Salmonella in raw chicken. Passive or indirect 
transmission may occur if the organism is simply present. No increase in loading dose is necessary. An 
example of passive transmission by common vehicle is food contaminated with Hepatitis A virus. The 
virus does not replicate in the food, but when the food is ingested, it may cause infection. 

Airborne spread is an efficient mode of transmission and may involve varying distances between the 
source and host. The most efficient means of airborne transmission is by droplet nuclei. Droplet nuclei 
are very small, about 1 to 5 pm, and can be suspended in air for extended periods of time. The size of 
the particle makes it ideal for inhalation because it is small enough to reach the respiratory tree without 
being swept up by cilia. The small size of the particle and its ability to remain suspended in air also 
means that droplet nuclei may spread through ventilation systems. Tuberculosis is the classic example 
of a disease spread by droplet nuclei. 

Table 10-2 Table 10-2. Portals of Entry and Exit 


Portals of Exit 

Portals of Entry 

Respiratory tract 

Respiratory tract 

Genitourinary tract 

Genitourinary tract 

Gastrointestinal tract 

Gastrointestinal tract 

Skin/mucous membrane 

Skin/mucous membrane 

Transplacental (mother to fetus) 

Transplacental (fetus to mother) 

Blood 

Parenteral (percutaneous via blood) 


Vectors, such as insects, also may transmit infectious organisms, although this method of transmission 
is of less importance in the hospital setting in most industrialized nations. External vectorborne 
transmission is the mechanical transfer of microorganisms by a vector, such as a fly on food. Internal 
vectorborne transmission involves transfer of infectious material directly from the vector into the new 
host, such as occurs in mosquitoes and malaria, fleas and plague, and louseborne typhus. The vector 
may simply harbor the infectious organism with no biological interaction taking place, or the agent may 
actually undergo changes within the vector (e.g., malaria parasites require that part of their life cycle 
take place within a mosquito). 

The portal of entry is the means by which an infectious agent enters the susceptible host. Portals of 
entry associated with human hosts are listed in Table 10-2. The susceptible host is the next link in the 
chain of infection. In addition to the characteristics of the susceptible host shown in Table 10-3, the 


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susceptible host has several nonspecific defense mechanisms that may modify the risks of becoming 
infected and developing disease. Normal (endogenous) flora in the host may protect it from other 
infectious organisms, and the host's natural antibodies attack some invading organisms. Natural barriers 
to the entry of organisms include (1) skin and mucous membranes, which provide mechanical barriers; 
(2) cilia of the respiratory tract and cough mechanism, which clear material from the respiratory 
structures; (3) gastric acid of the stomach, which helps destroy ingested pathogens; (4) mechanical 
flushing, which protects the genitourinary tract; and (5) tear flushing, which helps to protect the eye. 
Finally, good nutritional status protects the host overall. 

Salmonellosis can be studied in terms of the chain of infection. The causative agent of salmonellosis is 
Salmonella, a bacterium that can survive in the free state and generally has an infective dose of 
106 organisms or greater if the host has normal gastric acidity. Some strains of Salmonella typhi have 
much smaller infective doses. The reservoirs for Salmonella include humans, both carriers and active 
cases, and animals (including poultry, cattle, reptiles, and others). There are also environmental 
reservoirs for Salmonella, including contaminated food products, untreated sewage, and biological waste 
products (e.g., fertilizers, bone meal). The portals of exit are the gastrointestinal tract and, to a lesser 
extent, the genitourinary tract. Modes of transmission include both contact and common vehicles. Direct 
contact with the organism may occur while changing diapers or while handling raw poultry. Indirect 
contact by the hands of personnel may happen after handling an incontinent patient and then tube 
feeding the next patient without washing hands. Use of gloves should never replace hand hygiene 
because, although the gloves may reduce the likelihood of transmission, they may have microtears, and 
contaminated matter may get under the wrist area of the glove. Common vehicle transmission, in this 
case contaminated food, is a well-known mode of transmission for Salmonella. The portal of entry is the 
gastrointestinal tract and, although everyone is susceptible at some level, the elderly, the young, and 
those with decreased stomach acid are especially vulnerable. 

Table 10-3 Table 10-3. Host Characteristics Influencing Susceptibility to and Severity of Disease 


Characteristic 

Examples 

Age 

"Childhood diseases" are seen more frequently in children, whereas chronic diseases, such as heart 
disease or chronic obstructive pulmonary disease, occur more frequently in older patients 

Sex 

Reproductive diseases are sex-specific 

Ethnicity 

Tay-Sachs disease in Jews of European descent 

Socioeconomic status 

Ability to purchase healthcare services, food purchasing 

Marital status 

Some studies of stress-related diseases have shown marital status to be a factor influencing susceptibility 

Lifestyle 

Homelessness increases susceptibility due to poor nutrition and exposure 

Heredity 

Sickle cell anemia influences susceptibility 

Nutritional status 

Inadequate nutrition reduces immune function 

Occupation 

Coal miners are at risk for black lung 

Immunization status 

Those who have not been vaccinated for measles are at risk for the disease 

Diagnostic/therapeutic 

procedures 

Transplant patients have increased risk of infection 

Medications 

Steroid use increases risk of infection 


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Pregnancy Tuberculosis-positive women who are pregnant are more likely to reactivate 

Trauma Injury may provide portal of entry for organisms and triggers inflammatory response that may increase 

risk of infection 


Control of infectious diseases involves breaking the chain of infection by altering the host, the 
environment, or the agent. In the Salmonella example, measures directed at the agent and the reservoir 
includes proper storage, handling, and cooking of food and properly treating sewage to inactivate the 
organism. Educating cases and carriers about hygiene may also break the transmission of disease at 
the reservoir link in the chain of infection. The susceptible host breaks the chain through caution in 
cooking, eating, and hygiene habits. Environmental measures include restricting food handlers with 
disease, treatment of carriers (reservoir link), wearing of gloves when contact with stool or contaminated 
items is likely, and proper handwashing for patients and personnel providing care (transmission link). 

INTERRUPTING THE CHAIN OF INFECTION: EPIDEMIOLOGICAL STUDY 
DESIGN 

Epidemiology uses tools to determine risk factors for disease, and these may help to identify links in the 
chain of infection that may be interrupted or broken. Primary study designs used in the healthcare 
setting are described as prospective or retrospective. These studies are commonly used in relation to 
cohort and case-control studies, respectively. The prospective and retrospective designs result in 
observational studies, in which the investigator does not manipulate any components, but simply 
observes characteristics and outcomes. These studies describe the subjects in terms of person, place, 
and time. Essentially, they look at the "who," "where," and "when" of disease occurrence in an effort to 
determine the "why." 

In prospective or cohort studies, data are gathered over time. In this study design, a group of subjects 
with a known exposure status for the risk factor(s) of interest are followed over time to determine which 
of the subjects develops disease. These subjects form a cohort going through time together. 
Experimental studies are also prospective in nature. Data are gathered as subjects move from the 
present into the future while being followed up by the researcher. In contrast, case-control studies are 
referred to as retrospective—moving backward from disease state to risk factor by first identifying 
persons with the disease and then measuring their degree of exposure to the risk factor(s) of interest in 
the past (see Figure 10-7). 


Cause 

(exposure to 
risk factor) 


Cohort (prospective) 


Case-control (retrospective) 


Effect 

(disease) 


Figure 10-7. 


Contrasting prospective and retrospective 


investigation. 


View Image 


a 


Sometimes the terms prospective and 

retrospective are used in a temporal, rather than conceptual, sense. A cohort study that measures 
disease frequency in the present and among persons with a known exposure in the past is commonly 
called a "retrospective cohort study" (see Figure 10-8). Study and research designs are described more 
fully in Chapters 19 and 20 . 


ADVANTAGES AND DISADVANTAGES 

Both cohort and case-control studies have advantages and disadvantages. Retrospective studies use 
data already available, such as patient charts or laboratory databases. They also require relatively small 
numbers of subjects relative to cohort studies because a sufficient number of cases are already included 


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in the study, that is, the researcher does not have to wait for enough cases to develop to perform an 
analysis. This makes the case-control method useful for disease states that occur rarely. It also makes 
retrospective studies less expensive because fewer total subjects may be required for analysis, and data 
are already available. These studies also take less time than prospective studies because the cases are 
already identified and are commonly used in healthcare epidemiology and infection prevention to identify 
causes of outbreaks. However, case-control studies are dependent on the completeness of records, and 
it may be difficult to select an appropriate control group. Retrospective studies are used to get 
information about past events and are subject to recall bias because they rely on the memory of 
subjects and others for information on exposure. 

Prospective, or cohort, studies are usually more expensive than case-control studies in part because 
they take longer and generally require more study subjects. Long follow-up periods may be required 
while waiting for disease to occur in sufficient numbers for analysis. Attrition may result from long follow¬ 
up periods, reducing the sample size of a study. Traditionally, cohort studies are considered to have 
fewer bias issues than case-control studies because they avoid the subjectivity involved in collecting 
after-the-fact exposure data from persons already affected by disease. They also yield incidence rates 
because the population at risk has already been identified and can yield associations between risk 
factors and disease that were not anticipated. Cohort studies generally carry more weight and tend to 
be used when controversial retrospective findings need to be verified. 

RECOGNIZING OUTCOME-RELATED EVENTS 

Once epidemiological studies have been performed, it is important to recognize the outcomes of those 
studies to apply knowledge gained. Outcome events are useful in evaluation of an infection prevention 
and control program and may include decreased rates of infection, length of stay, days in intensive care 
units, and other measures. Modification of behaviors by HOP and learned skills by personnel can be 
measured by looking at outcomes. Changes in HAI rates can be determined (although extreme caution 
must be used in the interpretation of results because some HAIs are not preventable by known 
interventions). Changes in policies and procedures may result in changes in outcomes or may result 
from outcome differences. Being able to show outcomes from studies may result in priority modifications 
in the future for the infection prevention program or the facility. 

DATA PRESENTATION 

Once data have been gathered and analyzed, they must be presented clearly and concisely, greatly 
helping others to understand the study, why it was done, and the outcomes. Data are generally 
presented graphically in one of three forms: tables, graphs, or charts. All well-constructed tables, 
graphs, and charts present a limited amount of information that is easily understood, and, ideally, each 
can stand alone. Too much information simply becomes confusing, defeating the purpose of graphically 
presenting the data. Each presentation graphic must have a complete title that describes the contents in 
terms of the event being studied, the population being studied, and the place and time of study. For 
example, a complete title might be, "Reported cases of bacteremia in surgical intensive care unit 
patients, in Hospital X, in March, 2004." This title tells the reader much more than the alternative 
"Bacteremia in the SICU." When preparing tables, graphs, or charts, it is helpful to indicate the date 
they were prepared. This may be important because data often change over the course of an outbreak 
investigation, and dating graphics will help the researcher keep current and track changes. The source 
of data must be identified if data from an outside source are used in the table, graph, or chart. 

Figure 10-8. 

Retrospective and prospective cohort. 

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A few definitions of terms used View Image 0 
components of tables, graphs, and charts may 
be helpful. A cell is the space in a table, graph, 
or chart in which data are entered. The class 
interval is the subgrouping of values for any 
given epidemiological variable, such as age or 
sex. For example, "age" may be grouped into 
two class intervals: "younger than 15 years old" and "15 years and older." Continuous data are data for 
which there are an infinite number of possible values between the minimum and maximum values. 

Examples include age, weight, and temperature. This is in contrast to discrete data, which can be 
counted only in whole numbers, such as number of children. A coordinate is one of a pair of locators 
used to specify a particular point, for example, the x and y coordinates on a graph. 


Post 


Pr®»«nf 


Future 


Exposure to 
risk (odor 


Prospective 


cohort 


Exposure K 
risk factor 


cohort 


Diteose 


TABLES 

A table is a set of data arranged in rows and columns (Figure 10-9). Tables are used to present the 
frequency with which some event occurs and to present this information in different categories or 
subdivisions of a variable. Well-constructed tables are simple; ideally, they do not try to present more 
than three factors at a time. Readable tables have a clear, concise title that answers who, what, where, 
when, and how questions, that is, they provide information about person, place, and time. Each column 
and row should be labeled and the column and row totals shown, if they are used. Codes, 
abbreviations, and symbols should be explained in footnotes. Sources of information gathered from 
outside the institution or used for comparison should be cited. 


Figure 10-9. 

Elements of a well-constructed t , 

View Image 0 

GRAPHS 

Graphs are a method of showing quantitative 
data using a system of coordinates (Figure 10- 
10). A well-constructed graph consists of two 
sets of lines that intersect at right angles. Each 
axis (line) has a scale measurement and a 
label. By convention, the horizontal (x) axis 
reflects the variable time in whatever interval is 
being used (year, month, quarter, day, etc.) 
when time is to be presented. The vertical (y) axis usually reflects the frequency of occurrence of an 
event (e.g., the number of cases of disease) or the proportion (e.g., percent, cases per 1,000 patient 
days) with the event. More than one factor or variable can be shown on a graph, but each should be 
clearly differentiated by a legend or key. It is important to remember that each graph should be simple 
and self-explanatory. 

Figure 10-10. 



Elements of a well-constructed graph. 


View Image 0 


There are several forms of graphs used in the presentation of epidemiological data. The arithmetic line 
graph uses equal distances along the y axis to represent equal quantities anywhere on that axis (see 
Figure 10-10). The semi-logarithmic scale line graph uses a y-axis measured in logarithms of units. This 


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is often used when examining a series of data 
over long periods of time to compress what 
would be very large spaces between data points 
or to normalize the appearance of data, but use 
of "semilog" must always be acknowledged both 
in the graph itself and in the text regarding the 
graph. A histogram is a graphic of a frequency 
distribution in which one bar is used for each 
time interval, and there is no space between 
the intervals (see Figure 10-11). This type of 
graph is used to depict an epidemic curve. A 

frequency polygon is similar to a line graph, but each coordinate point is represented by a point 
displayed on the graph with straight lines connecting them. A frequency polygon will provide the same 
data information as a histogram. 



Figure 10-11. 

Elements of a properly construe 

View Image 

CHARTS 

A chart is a method of illustrating information 
using only one coordinate. Charts are used to 
compare magnitudes of different events and to 
compare parts of a total picture. Types of charts 
include bar charts, geographical coordinate charts, pictograms, and pie charts. Bar charts use bars to 
depict the event being studied (see Figure 10-12). The bars are the same column width and, unlike 
histograms, are separated by spaces. Bar charts can be used to compare magnitudes, show frequency 
distributions, and show time-series data. The pictogram is a variation of a bar chart that uses a series 
of small identifying symbols to represent the data. Geographical coordinate charts represent the 
occurrence of events using maps. Spot maps use dots or symbols at each location where an event took 
place (e.g., patient rooms with a dot for each patient with a disease). An area map uses shaded or 
coded areas to show the distributions of some conditions (e.g., color codes of wards based on the 
number of patients in the area with a given condition). The pie chart is used to represent proportions in 
the form of percents by assigning them to wedge-shaped portions of a circle for comparison so that the 
entire "pie" is 100 percent (see Figure 10-13). A pie chart is not appropriate when there are many 
wedges—limit the number to five or six. 



tflporirt com o i 4>mom * by it upo*. 

UntadSoOt. 1995 


Figure 10-12. 



U-charts are gaining popularity in infection 
prevention. These provide statistical process 
control (SPC) information to help monitor quality 
assurance and are most often used for 
monitoring length of stay and infection rates. 
These charts use calculated upper and lower limits over time, and the statistical or other (Excel) 
programs can be used to generate rates, limits, averages, and such for use in constructing control 
charts. Essentially, the control chart, in this case the U-chart, provides a range of expected variation 


Comparison of a histogram and its 
corresponding frequency distribi 

View Image 


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about a mean (centerline) and the upper and lower limits (upper control limit and lower control limit) 
beyond which the process is considered out of control. These charts can be particularly useful in 
conveying changes in rates over time and identifying points in time when infection rates or other 
processes are outside the expected range. The control chart is specifically designed to show when a 
process is out of control, unstable, or unpredictable. Processes that are out of control (i.e., increasing 
infection rate) can be identified, and prevention efforts put in place to regain control or increase stability. 
The U-chart is one of several SPC charts available but is useful in infection prevention because there 
can be more than one error (i.e., infection) per patient taken into account. The caveat to SPC charts is 
that they can be less stable with small denominators. Control charts are discussed more fully and 
examples provided in Chapter 14. Process Control Charts . 

Figure 10-13. 

Estimated average percentage of annual 
traumatic brain injuries by external causes in 
the United States, 2002-2006. (From Centers 
for Disease Control and Prevention. Traumatic 
Brain Injury in the US. CDC Website. 2012. 
Available at: 


httD://www.cdc.aov/Features/dsTBI Braininiurv/.) .... .—, 

- - 3 - 1 — ' View Image £S] 

Conclusions 

In summary, an infection preventionist's basic understanding of epidemiological methods is crucial for a 
well-functioning infection prevention and control program. These methods form the basis of all studies 
and outbreak investigations conducted and in the assessment of programs developed. Understanding 
basic epidemiological methods will lead to better study design and studies that are more likely to 
provide accurate and comparable information for creating change to reduce HAI rates and clear and 
concise data presentation so that changes in rates, causes of outbreaks, and so forth can be easily 
understood by healthcare facility administration and HCP. 

Supplemental Resources 

1. Abramson JH, Abramson ZH. Making Sense of Data: A Self-instruction Manual on the 
Interpretation of Epidemiological Data, 3rd ed. New York: Oxford University Press, 2001. 



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2. Arthur J. Statistical process control for health care. QuaI Dig 2008;28(6):34-38. 

3. Benneyan JC. Design, Use and Performance of Statistical Control Charts for Clinical Process 
Improvement. Northwest Portland Area Indian Health Board Website. 2001. Available at: 
http://www.npaihb.org/images/training_docs/NARCH/2010/Benneyan%20SPC%20chart%20. 

4. Boyce JM. Environmental contamination makes an important contribution to hospital epidemiology. 
J Hosp /nfecf2007;65(Suppl 2):50-54. 

5. de Vet HCW, Terwee CB, Mokkink LB, et al. Measurement in Medicine: A Practical Guide. New 
York: Cambridge University Press, 2011. 

6. Friedman GD. Primer of Epidemiology, 5th ed. New York: McGraw-Hill, 2004. 

7. Gordis L. Epidemiology, 4th ed. Philadelphia: Saunders Elsevier, 2008. 

8. Heyman DL, ed. Control of Communicable Disease Manual, 19th ed. Washington, DC: American 
Public Health Association, 2008. 

9. Jarvis WR, ed. Bennett and Brachmans's Hospital Infections, 5th ed. Philadelphia: Lippincott 
Williams & Wilkins, 2007. 

10. Kramer MS. Clinical Epidemiology and Biostatistics: A Primer for Clinical Investigators and 
Decision-Makers. Berlin: Springer-Verlag, 2011. 

11. Last JM, ed. A Dictionary of Public Health. New York: Oxford University Press, 2007. 

12. Mayhall CG, ed. Hospital Epidemiology and Infection Control, 4th ed. Philadelphia: Lippincott 
Williams & Wilkins, 2011. 

13. Norman GR, Streiner DL. Biostatistics: The Bare Essentials, 3rd ed. Hamilton, Ontario, Canada: 
BC Decker, 2008. 

14. Norman GR, Streiner DL. PDQ Epidemiology, 3rd ed. Shelton, CT: People's Medical Publishing 
House, 2009. 

15. Porta M, ed. Dictionary of Epidemiology, 5th ed. Oxford: Oxford University Press, 2008. 

16. Rothman KJ, Greenland S, Lash TL. Modern Epidemiology, 3rd ed. Philadelphia: Lippincott 
Williams & Wilkins, 2008. 

17. Selvin S. Statistical Analysis of Epidemiologic Data, 3rd ed. New York: Oxford University Press, 
2005. 

18. Wenzel RP, ed. Prevention and Control of Nosocomial Infections, 4th ed. Baltimore: Williams & 
Wilkins, 2002. 

19. Woodward M. Epidemiology: Study Design and Data Analysis, 3rd ed. Boca Raton, FL: Chapman 
and Hall/CRC, 2013. 

References 


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Copyright © 2016 by the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) 

All rights reserved. Intended for personal use only. No part of this publication may be reproduced, stored in a retrieval system, or 
transmitted, in any form or by any means, electronic, mechanical, photocopied, recorded or otherwise, without prior written 
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APIC 

XrVT OF INFECTION CONTROL 
I txV I AND EPIDEMIOLOGY 


Surveillance 


Author(s): Kathleen Meehan Arias, MS, MT, SM, CIC 
Director 

Arias Infection Control Consulting, LLC 
Crownsville, MD 

Published: March 10, 2016 


Abstract 

Surveillance is an essential component of an effective infection prevention and control program. This 
chapter discusses the history, evolution, and use of surveillance programs in healthcare settings. It 
outlines the steps that should be used when designing and evaluating a surveillance program; 
emphasizes the importance of using sound epidemiological and statistical principles; and stresses the 
use of surveillance data to improve the quality of healthcare. It reviews factors that affect surveillance 
programs in healthcare facilities, such as the changing healthcare delivery system, emerging and 
reemerging infectious diseases, and mandatory reporting requirements. This chapter also identifies new 
developments, future trends, and international issues related to surveillance in healthcare settings. 

Key Concepts 

• Surveillance programs should be based on sound epidemiological and statistical principles. 

• Surveillance methodology continues to evolve as the healthcare delivery system shifts outside of the 
traditional acute care hospital. 

• A surveillance program should be designed in accordance with current recommended practices and 
should consist of defined elements. 

• Surveillance activities should support a system that can identify risk factors for infection and other 
adverse advents, implement risk-reduction measures, and monitor the effectiveness of interventions. 

• Surveillance plays a critical role in identifying outbreaks, emerging infectious diseases, multidrug- 
resistant organisms, and bioterrorist events so that infection prevention measures can be instituted. 

• Surveillance programs in healthcare organizations should be integrated to include infection prevention, 
performance improvement, patient safety, and public health activities. 

• Mandatory and public reporting requirements significantly affect surveillance programs. 


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Background 

Surveillance can be defined as "a comprehensive method of measuring outcomes and related processes 
of care, analyzing the data, and providing information to members of the healthcare team to assist in 
improving those outcomes."lSurveillance is an essential component of an effective infection prevention 

and control program. 2,3 

In 1958, in response to nationwide outbreaks of Staphylococcus aureus infections in hospitals, the 
American Hospital Association recommended that hospitals implement a healthcare-associated infection 
(HAI) surveillance program.4ln the 1960s, the Centers for Disease Control and Prevention (CDC) 

recommended that hospital-based infection prevention and control programs incorporate surveillance 
activities and, in 1976, The Joint Commission (TJC) first included infection surveillance, prevention, and 
control standards in its requirements for hospital accreditation.sThe Study on the Efficacy of Nosocomial 

Infection Control (SENIC Project) provided scientific evidence that hospitals that had strong surveillance 
programs coupled with strong prevention and control programs were able to improve patient outcomes 
by reducing HAI rates.6Since the publication of the SENIC Project results in 1985, much has been 

published regarding the use of surveillance to monitor healthcare processes and practices and HAIs. 

Since the 1980s, the healthcare delivery system has dramatically shifted outside of the traditional acute 
care hospital, resulting in an increasing need for surveillance programs in other healthcare settings. 3 ,7ln 

response to this shift, infection prevention organizations have published recommendations for 
surveillance in out-of-hospital settings. 1 , 3 ,sState, federal, and accrediting agencies now require infection 

surveillance and prevention programs in a variety of healthcare settings, including hospitals, long-term 
care (LTC), rehabilitation, ambulatory surgery, dialysis, home care, mental health, and corrections 
facilities. 

Since the early 2000s in response to demands for more public information on HAIs, state and federal 
government agencies have increasingly mandated the reporting of infection-related data. The 
implementation of these requirements has created resource and technological challenges. 9 Other 

factors affecting surveillance programs include shorter hospital stays, the aging of the population, 
increased use of invasive procedures and devices, more acutely ill patient and resident populations, 
healthcare personnel shortages, emerging and reemerging infectious diseases, and the threat of 
bioterrorism.7 As healthcare practices evolve, new diseases emerge, antimicrobial resistance spreads and 

mandatory reporting requirements increase, new surveillance methodologies are needed to meet the 
changing environment. 

Surveillance can be used for the following purposes: 

• Determine baseline and endemic rates of occurrence of a disease or event 

• Detect and investigate clusters or outbreaks 

• Assess the effectiveness of prevention and control measures 

• Monitor the occurrence of adverse outcomes to identify potential risk factors 

• Provide information that can be used by an organization to target performance improvement activities 

• Measure the efficacy of interventional and performance improvement efforts 


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• Observe practices, such as hand hygiene, central line insertion, and sterilizer performance monitoring, 
to promote compliance with recommendations and standards 

• Detect and report notifiable diseases to the health department 

• Identify organisms and diseases of epidemiological importance, such as multidrug-resistant organisms 
(MDROs) and tuberculosis, to prevent their spread 

• Ensure compliance with requirements of federal regulators, such as the Occupational Safety and 
Health Administration (OSHA) and the Centers for Medicare & Medicaid Services (CMS) 

• Ensure compliance with state regulations and state mandatory reporting requirements 

• Meet requirements of accrediting agencies, such as The Joint Commission and the Accreditation 
Association for Ambulatory Health Care 

• Provide information for the education of healthcare personnel 

• Monitor injuries and identify risk factors for injuries of personnel 

• Detect a bioterrorist event or an emerging infectious disease 

• Provide data to conduct a facility risk assessment. 

Surveillance data have been used successfully in a variety of healthcare settings to reduce the 
occurrence of infections when used to identify risk factors, implement risk reduction measures, and 
monitor the effectiveness of interventions.6, 10 , 11 , 12 , 13,14 , 15 , 16 , 17 , is, 19 

This chapter reviews the basic principles, terms, and definitions used in surveillance programs in 
healthcare settings. It also discusses surveillance methodologies, key elements of a surveillance 
program, using surveillance data for performance improvement, the use of information technology, new 
developments, future trends, international issues, and provides a list of supplemental resources for 
obtaining additional information. 

Basic Principles 

Surveillance programs should be based on sound epidemiological and statistical principles. If 
surveillance data are properly collected and analyzed, they can provide information that can be used to 
improve the quality and outcomes of healthcare and to promote public health. Those who are 
responsible for implementing and assessing surveillance programs should be familiar with the general 
principles of epidemiology that are discussed in other chapters of this text. 

DEFINITIONS 

The following are definitions of terms, as used in healthcare surveillance. Many of the definitions are 
adapted or taken from the glossary in Principles of Epidemiology in Public Health Practice: An 
Introduction to Applied Epidemiology and Biostatistics , third edition. 20 

Attack rate.an incidence proportion, rather than a true rate, that is used to measure the frequency of 
new cases of a disease or condition in a specific population during a limited period. It is usually used to 
describe the proportion of the population that develops a disease or condition during an outbreak. 

Baseline-, the number or value used as the basis for comparison. 

Case: an instance of a particular disease, injury, or other health condition that meets selected criteria. 


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Case definition: a set of uniformly applied criteria for determining whether a person should be identified 
as having a particular disease, injury, or other health condition; usually specifies clinical, laboratory, and 
other diagnostic criteria. 

Cluster, a group of cases that occurs closely related in time and place without regard to whether the 
number of cases is more than expected (often the expected number is not known). 

Denominator: the lower portion of a fraction used to calculate a rate or ratio. 

Distribution: frequency and pattern of an event in a population. 

Endemic: usual presence of a disease or condition in a specific population or geographical area. 

Epidemic: the occurrence of more cases of a disease than expected in a given area or among a specific 
group of individuals during a specified time period; synonym of outbreak. 

Epidemiology: the study of the distribution and determinates of health conditions or events in specified 
populations and the application of this study to the control of health problems. 

Incidence rate: a measure of the frequency with which an event occurs in a population over a defined 
time period. The numerator is the number of new cases occurring during the defined time period, and 
the denominator is the population at risk. 

Outcome: the result of care or performance activities. 

Numerator: the upper portion of a fraction used to calculate a rate or ratio. In surveillance, it is usually 
the number of cases of a disease or event being studied. 

Population: the total number of individuals in a specified place or group. 

Prevalence: the number of cases or events or conditions occurring in a population. 

Prevalence rate: the proportion of persons in a population who have a particular disease or condition at 
a specified point in time (point prevalence) or over a specified period (period prevalence). 

Proportion: a type of ratio in which the values in the numerator are included in (i.e., are a subset of) the 
denominator. 

Process: the series of steps or activities taken to achieve an outcome. 

Rate: an expression of the frequency with which an event occurs in a defined population per unit of 
time. In healthcare surveillance, it is often used more casually to refer to proportions that are not truly 
rates (e.g., attack rate or incidence density rate). 

Ratio: the value obtained by dividing one quantity by another. 

Sensitivity: the ability of a test, case definition, or surveillance system to identify true cases or persons 
who have the health condition of interest (i.e., the proportion of persons with a health condition that are 
correctly identified by a test or case definition as having the health condition). 

Specificity: the ability of a test, case definition, or surveillance system to exclude persons who do not 
have the health condition of interest (i.e., the proportion of persons without a health condition that are 
correctly identified by a test or case definition as not having the health condition). 


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Validity : the degree to which a measurement, test, study, or other data collection method actually 
measures or detects what it is intended to measure. 

BASIC STATISTICAL MEASURES USED FOR SURVEILLANCE 

Common statistical measurements used in surveillance programs in the healthcare setting are measures 
of frequency (e.g., rates, ratios, and proportions), measures of central tendency (e.g., mean and 
median), measures of dispersion (e.g., standard deviation), and percentiles. Because statistical methods 
are discussed in detail in other chapters of this text, they are only described briefly here. 

Measures of Frequency 

Rates, ratios, and proportions are used to measure the occurrence and risk of an event in a specific 
population during a given period. These frequency measures are based on the same formula: 

x &divide; y&times; 10 n , where the numerator and the denominator represent the two groups being 
compared and the multiplier 10 n is used to transform the result into a number that is larger than one. 

Ratios and Proportions 

A ratio is a fraction in which the values in the numerator (x) may or may not be included in the 
denominator (y). A ratio can be used to express a relationship between two independent groups. The 
device utilization ratio used in the National Healthcare Safety Network (NHSN) is determined by dividing 
the number of device-days by the number of patient-days. 21 This is an example of a ratio in which the 

values in the numerator (device-days) are independent of the values in the denominator (patient-days). 

A proportion is a ratio in which the population in the numerator is a subset of the population in the 
denominator. A proportion is frequently expressed as a percentage. 

Examples using ratios and proportions: 

In a 12-month period, six patients in a critical care unit developed a ventilator-associated condition 
(VAC); four cases are female and two are male. 

1. The ratio of female cases to male cases is determined using the formula x &divide; y&times; 10 n in 
which xis 4, yis 2, and 10 n is 1 (n = 0). The ratio of females to males would be 4 &divide; 2 
&times; 1 = 2 &divide; 1 or 2:1. Thus, there are two females for every male, or twice as many 
females as males who developed a VAC. In this ratio, the values in the numerator (females) are 
not included in the denominator (males). 

2. The proportion of the six VAC cases that are male would be calculated using the formulax &divide; 
y&times; 10 n in which xis 2, yis 6, and nis 0. The proportion of cases that are male would be 2 
&divide; 6 &times; 1 = 1 &divide; 3 or 1:3. Thus, one-third, or one of every three, VAC cases are 
male. This proportion can be expressed as a percentage if 10 n is 100 (n= 2) where 2 &divide; 6 
&times; 100 = 33 percent. In a proportion, the values in the numerator are always a subset of 
those in the denominator. 


Rates 

A rate is a measure of the occurrence of an event in a defined population in a defined time. A rate has 
a time dimension. Rates can be used to track trends and to monitor changes in the frequency of an 
event in a population from one time period to another (e.g., the occurrence of bloodstream infections in 
patients in an intensive care unit [ICU] before and after interventions implemented to reduce the risk of 


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infection). The most commonly used rates in surveillance programs for healthcare settings are 
incidence, attack, and prevalence. 

An incidence rate measures the occurrence of new cases or events in a specific population during a 
given time period. The formula for calculating an incidence rate is x &divide; y&times; 10 n where x(the 
numerator) is the number of new cases or events in a population during a given time period, y(the 
denominator) is the number in the population at risk during that time period, and 10 n is used to 
transform the result into a number that is larger than one. The numerator in an incidence rate 
calculation is always the number of new cases in a specified period. However, the denominator differs 
depending on the study being conducted. 20 For surveillance in healthcare facilities, the denominator is 

frequently the number of the average population observed in a specified time period or the cumulative 
person-time the population was at risk in a specified time period. In a person-time incidence rate, the 
denominator is the sum of the time each person was at risk in a specified time period, totaled for all 
persons. Examples of incidence rate calculations using cumulative person-time: 

1. In March, there were three central line-associated bloodstream infections (CLABSIs) and 491 
central line-days in an ICU. The calculation for the CLABSI rate in the ICU in March is the number 
of CLABSIs in ICU patients in March &divide; the number of central line-days in ICU patients in 
March &times; 1,000, or 3 &divide; 491 &times; 1,000 = 6.1. In this example, 10 n = 1,000 (n- 3) so 
that the result is larger than one. This rate is expressed as 6.1 CLABSIs per 1,000 central line- 
days in the ICU in March. 

2. In June, there were two resident falls in an LTC unit that had 275 resident-days. The calculation 
for the fall rate would be the number of falls in the LTC unit in June &divide; the number of 
resident-days in the LTC unit in June &times; 1,000, or 2 &divide; 275 &times; 1,000 = 7.3. In this 
example, the rate is expressed as 7.3 falls per 1,000 resident-days in the LTC unit in June. 

An attack rate, which is actually an incidence proportion rather than a true rate, is generally used to 
describe the frequency of cases during an outbreak. 20 The formula is x&divide;y&times; 10 n where x(the 

numerator) is the number of new cases or events in a population during a given time period, y(the 
denominator) is the number in the population at risk during that time period, and the result is usually 
expressed as cases per 100 population, or as a percentage (i.e., where nis 2 and 10 n = 100). 

Example attack rate calculation: 

Eleven of 46 individuals developed acute gastroenteritis within 24 hours of eating at a luncheon. The 
attack rate for gastroenteritis among the luncheon attendees would be calculated by dividing the number 
of individuals with gastroenteritis (x = 11) by the number of those that ate at the luncheon (y = 46) and 
multiplying by 10 2 or 100 (to provide a percentage). The attack rate is 11 &divide; 46 &times; 100 = 23.9 
percent. 

Prevalence measures the occurrence of existing (old and new) cases in a specific population during a 
given time period. The formula for prevalence is the number of existing cases in a population during a 
specific time period &divide; number in that population during that time period &times; 10 n . 

Examples of prevalence calculation: 

On April 1, a study was done in an LTC facility to determine the point prevalence of residents being 
treated with an antibiotic. On that day, there were 120 residents and 62 were on antibiotic therapy. The 
point prevalence of residents being treated with an antibiotic is calculated by dividing the number of 
residents receiving antibiotic therapy (x= 62) by the number of residents in the facility on that day (y= 


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120) and multiplying by 10 2 or 100 (to provide a percentage). The point prevalence is 62 &divide; 120 
&times; 100 = 51.7 percent. 

Measures of Central Tendency 

Measures of central tendency describe the values around the middle of a set of data. 20 Two measures 

of central tendency used in healthcare surveillance are the arithmetic mean and the median. The mean 
is the mathematical average of the values in a set of data. Although the mean is commonly used, it is 
important to remember that its value is affected by outliers (extremely low or high values). The median 
is the middle value in a ranked set of data. Because half of the measurements in the data set lie below 
the median and half of the measurements lie above it, the value of the median is not affected by 
outliers. 

Measures of Dispersion 

Measures of dispersion measure the distribution of a set of data around its mean (mathematical 
average). Commonly used measures of dispersion in hospital epidemiology are the range, deviation, 
variance, and standard deviation. 

The range is the difference between the smallest value and the largest value in a set of data. The 
deviation is the difference between an individual value in a data set and the mean (average) for the set. 
Variance is the deviation around the mean of a distribution. The standard deviation is a measure that 
reflects the distribution of values around the mean. 

Percentiles 

Percentiles are used to indicate the relative position of a measurement with respect to other 
measurements in a set of data. The median is the 50th percentile in a distribution of numbers because 
half of the values in the distribution are lower and half are higher than the median value. In addition to 
the median, percentiles that are commonly used for reporting surveillance data are the 10th, 25th, 75th, 
and 90th percentiles. 

The CDC NHSN reports percentile distributions for device-associated infection rates and device 
utilization ratios among participating facilities. 21 Healthcare organizations that collect and analyze their 

data using NHSN methodology can use the NHSN data for comparison and benchmarking. An appendix 
in the NHSN Data Summary Reports for the device-associated module provides instructions on how to 
interpret percentiles of infection rates or device utilization ratios. 21 Additional information on how to use 

and calculate these statistical measures can be found in other chapters of this text and in the 
Supplemental Resources section at the end of this chapter. 

SURVEILLANCE METHODOLOGIES 

Total (or Whole) House Surveillance 

In total (or whole) house surveillance, all HAIs are monitored in the entire population of a healthcare 
facility. When total house surveillance is conducted, an overall facility infection rate should not be 
calculated; rather, rates should be calculated for specific HAIs in defined populations in the facility, such 
as CLABSIs in an ICU or surgical site infections (SSIs) related to a specific operative procedure. Overall 
rates have long been discouraged by most experts because crude overall rates are not sensitive 
enough to identify potential problems and therefore cannot be used to target performance improvement 


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activities. 22 , 23,24 In addition, because overall rates are not adjusted for specific infection or injury risks, 

they are not appropriate for measuring trends over time, making comparisons between groups either 
within a facility or between facilities, or benchmarking. 23 Although it is ideal to monitor all infections in 

the entire population in a facility, many healthcare organizations do not have the technical and 
personnel resources needed to do so, and targeted surveillance is generally conducted. 

Targeted Surveillance 

In the 1990s, the CDC shifted the National Nosocomial Infections Surveillance/NHSN system away from 
total hospital surveillance to focus on targeted surveillance in defined populations. 25 Targeted 

surveillance focuses on particular care units (e.g., a nursery or ICU), infections related to medical 
devices (e.g., intravascular and urinary catheters), invasive procedures (e.g., surgery), and organisms of 
epidemiological significance (e.g., methicillin-resistant Staphylococcus aureus[ MRSA]). 21,26 Targeted 

surveillance usually focuses on high-risk, high-volume procedures and on those HAIs and adverse 
outcomes that are potentially preventable. 1 , 24,26 The CDC Targeted Assessment for Prevention (TAP) 

strategy utilizes NHSN data to target prevention strategies specific to each facility and allows the CDC 
to identify facilities with the greatest need for improvement. TAP reports include the metric, Cumulative 
Attributable Difference (CAD) which yields a specific number of infections that must be prevented in 
order to reach established HAI reduction goals. CDC encourages Infection Preventionists to utilize 
specific TAP reports and CAD metric that represent concrete prevention goals that are linked to 
standardized infection rates (SIR). 

Combination Surveillance Strategy 

In practice, many infection prevention and control programs use a combination of targeted and modified 
total house surveillance. Many programs monitor targeted events that occur in a defined population, 
such as catheter-associated urinary tract infections (CAUTIs) in an ICU, while concurrently monitoring 
selected HAIs and laboratory reports from facilitywide locations. For instance, laboratory reports can be 
monitored housewide to detect the following: MDROs (e.g., MRSA and vancomycin-resistant enterococci 
[VRE]), reportable diseases, organisms of epidemiological importance, and clusters that may indicate an 
outbreak or breakdown of infection prevention practices (e.g., several cases of diarrhea associated with 
Clostridium difficile on a medical care unit). 

ELEMENTS OF AN EFFECTIVE SURVEILLANCE PROGRAM: SURVEILLANCE 
PROGRAM DESIGN 

Much has been published about developing and evaluating surveillance programs. 1 , 8 , 22 , 23,27 The 
following steps should be taken when designing a surveillance program for a healthcare setting. 

Select the Surveillance Methodology 

A surveillance program may measure all infections (i.e., total surveillance) or may be focused (targeted) 
on events selected by an organization. 22,26 As discussed previously, when total house surveillance is 

done, an overall infection rate should not be calculated. 22,23 


Assess and Define the Population(s) to be Studied 


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Each organization should assess its patient, resident, and employee populations and identify those that 
have the greatest risk for infection or other adverse outcome. 1,22 This is done by assessing the types of 

persons served (e.g., newborn, pediatric, adult, geriatric), healthcare services provided (e.g., medical, 
surgical, rehabilitation, LTC, ambulatory care, long-term acute care), surgical and other invasive 
procedures performed, and the conditions and diseases present in the population. 

Choose the Events to Monitor 

One of the most important steps in designing a surveillance program is the selection of appropriate 
health-related events to monitor. 1,22 Surveillance programs should measure outcomes of healthcare, 

processes of healthcare, and selected events of importance to the organization. 1,22 Some monitored 

events should focus on personnel. 

The events chosen should be based on the following: 

• Type of healthcare setting 

• Populations being studied (including patients, residents, and healthcare personnel) 

• Procedures performed and services provided 

• Acuity of care 

• A risk assessment that identifies risk factors for infection and other adverse events in the populations 
studied 

• State, federal, accrediting, and other relevant agency requirements, including mandatory reporting 
requirements 

• Available resources, both personnel and nonpersonnel 

• Availability of the data required 

• Public health needs 

• Performance improvement initiatives 

• Organizational objectives 

It is common to monitor high-volume, high-risk events in a specific population. Monitor events that have 
the potential to provide information that can be used to improve outcomes and infection prevention 
practices. Examples of outcome events that may be monitored include the following: 

• HAIs (e.g., bloodstream, urinary tract, pneumonia, surgical site, conjunctivitis, upper respiratory tract, 
or local intravenous site) 

• Infection or colonization with a specific organism (e.g., C. difficile, MRSA, VRE, or other MDROs, 
respiratory syncytial virus [RSV] or rotavirus) 

• Phlebitis related to peripheral intravascular therapy 

• Pyrogenic reaction or pus, redness, or increased swelling at a dialysis vascular access site in 
hemodialysis patients 

• Sharps injuries and communicable disease or blood/body fluid exposures in healthcare personnel 

• Tuberculin skin test conversion rates in healthcare personnel 

• Influenza immunization rates in personnel, residents, or patients 

• Hepatitis B immunization rates in personnel 


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• Examples of process events include the following: 

• Personnel compliance with infection prevention protocols, such as: 

° Standard precautions 

° Isolation precautions 

o Central line insertion, maintenance, and removal 
° Urinary catheter insertion, care, and removal 
° Safe injection and medication handling practices 
° Tuberculin skin testing 
° Hand hygiene 
° Instrument processing 
° Sterilization quality assurance testing 
o Environmental cleaning and disinfection 
° Communicable disease reporting 
° Antimicrobial prescribing and administration 

° Installing and maintaining barriers during construction and renovation projects 
Examples of other events of significance that may be monitored include the following: 

• Occurrence of reportable diseases and conditions 

• Communicable and potentially communicable diseases in personnel 

• Organisms or syndromes indicative of a bioterrorist event 

• Results of quality assurance testing (e.g., monitoring of negative airflow in airborne infection isolation 
rooms, biological monitoring of sterilizers, and testing of high-level disinfectants) 

• Admission of a patient or resident known to be infected or colonized with an MDRO 

An effort should be made to select events that have validated, nationally available benchmark data that 
can be used for meaningful comparison, such as the NHSN and the Vermont Oxford Network for 
monitoring the medical care of newborns. 

If rates are to be calculated, both the number of cases (i.e., persons who have the condition) and the 
number in the total population at risk for that condition must be identifiable. Rates, rather than raw 
numbers, must be used to accurately track trends over time. 

Select events that incorporate a risk adjustment or risk stratification method whenever possible. 1 , 21,22 

For instance, the CDC NHSN event for CAUTI measures the development of a UTI associated with the 
risk of an indwelling urinary catheter in a defined population. For many years, patients in the NHSN SSI 
event module were stratified using a basic risk index based on duration of the surgical procedure, 
wound classification, and American Society of Anesthesiologists (ASA) score. 28 The NHSN SSI event 

module now uses procedure-specific risk models that incorporate additional risk factors such as gender, 
age, emergency, trauma, general anesthesia, medical school affiliation, number of hospital beds, 
endoscope, and outpatient. 29,30 


Determine Time Period for Observation 


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Collect surveillance data for each indicator consistently and for a defined period, such as a month, 
quarter, or year. It is difficult to interpret rates for events that rarely occur and procedures that are 
infrequently performed. Therefore, if uncommon events are measured and rates are calculated, it is 
necessary to use an observation period that is long enough to accumulate a sufficient number of events 
for the measurement to be valid. 

Identify Surveillance Criteria (Case Definitions) 

To accurately trend surveillance data over time within a facility, or compare rates between facilities, 
surveillance criteria (i.e., case definitions) must be consistently used to determine the presence of an 
HAI, occurrence of an event, or compliance with a process. If a case definition is changed, this should 
be noted in the surveillance report because the number of cases identified will likely change and the 
rate will be affected. Use criteria that reflect generally accepted definitions of the disease or event being 
monitored. Criteria have been published for defining HAIs in a variety of healthcare settings, including 
hospitals, LTC, and home care. 30 , 31 , 32,33 In the United States, the majority of healthcare facilities, and 

many government mandatory reporting programs, use the NHSN surveillance criteria and methodology.34 

Individuals who conduct surveillance activities and identify HAI cases must apply surveillance criteria 
precisely. It should be noted that criteria used to define a case for surveillance purposes may be 
different than criteria used clinically for diagnosis and treatment. This is because surveillance definitions, 
such as those used in the NHSN, were developed for epidemiologic surveillance and not for clinical 
diagnosis. For instance, the NHSN surveillance criteria used to identify a central line- 
associated bloodstream infection can differ from the clinical criteria used to diagnose and treat a 
catheter-related bloodstream infection. 35,36 Therefore, a patient may fit the surveillance criteria for a 

CLABSI but may not be clinically diagnosed as having a catheter-related infection. 

Identify Data Elements to be Collected 

The data elements that should be collected depend on the event being monitored and the statistical 
measures used to analyze the data. To use time and personnel resources efficiently, data collection 
should be limited only to those elements that are needed to identify a case and determine whether the 
case criteria are met for the condition or event being studied. 

Data elements that may be collected include the following. 

For an infectious event: 

1. Case name; sex; age, unique identifier such as medical record or account number; unit or location 
in the facility; physician name and service; date of admission; date of onset of infection; type of 
infection; and date of discharge, transfer, or death 

2. Information needed to determine whether the case definition is met: results of laboratory and 
diagnostic tests specified in the case definition, and dates performed; sites and dates cultured and 
organisms isolated; antibiotic susceptibility of significant isolates; and clinical signs and symptoms 
specific for the infection being monitored 

3. Risk factors for the infection being monitored: host factors such as underlying conditions and 
diseases; surgical procedure and date performed; surgeon; use of intravascular catheters, 
including date of insertion, duration of use (vascular catheter-days), catheter type and body site; 
use of a urinary catheter, including date of insertion and duration of use (urinary catheter-days); 
mechanical ventilation and dates and duration of use (ventilator-days) 


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For a noninfectious event: 

Case name; sex; age; unique identifier such as medical record or account number; unit or location in 
the facility; physician name and service; date of admission; primary diagnosis; date, time, and location 
of event; outcome (e.g., severity of injury); personnel involved; risk factors for the event; and date of 
discharge, transfer, or death. 

Determine Methods for Data Analysis 

Before data collection is initiated, the statistical measures that will be used to analyze the data must be 
determined so the requisite data can be collected. If rates or ratios will be calculated, the values 
corresponding to each numerator and denominator must be defined, and the appropriate data needed 
to calculate each rate or ratio must be collected. 

Whenever possible, data should be expressed as rates or ratios that are calculated using the same 
methodology as a nationally validated surveillance system. This allows an organization to compare its 
rates with another organization or a recognized benchmark. For instance, if ventilator-associated events 
(VAEs) are monitored using the NHSN criteria and methodology, both the number of cases in a specified 
population that fit the VAE criteria (numerator data) and the total number of ventilator-days in that 
population (denominator data) must be identified to calculate VAE rates that can be properly compared 
with NHSN data. 37 


Determine Methods for Data Collection and Management 

Data may be collected concurrently (while a person is still under the care of the organization) or 
retrospectively (closed-record review after discharge). 22 The advantages of concurrent surveillance are 

as follows: data collectors may interview caregivers or observe the patient or resident if the chart does 
not include the information needed to fulfill the case criteria; immediate prevention and control 
measures, such as isolation precautions, may be instituted; clusters and outbreaks can be detected in a 
timely manner; and infection prevention personnel are available to identify and correct potential 
problems and provide education to personnel, visitors, and patients or residents. The disadvantages of 
concurrent surveillance are the time involved in locating records on a medical care unit (if paper records 
are being used) and incomplete medical records. The major advantage of retrospective review is that 
the medical record is more complete. The disadvantage of retrospective surveillance is that important 
findings, such as the identification of an outbreak, may be delayed and missing information may not be 
obtainable after discharge. 

Sources of surveillance data include the following: 

• Medical records (paper and electronic) 

• Daily reports generated by the laboratory (e.g., microbiology, immunology, and serology results) 

• Daily list of admissions, including diagnosis 

• Monthly reports of patient-days and census data, by unit 

• Nursing care plan (Kardex or computerized plan) 

• Interviews with caregivers 

• List of patients or residents on isolation precautions 

• List of prescribed medications from the pharmacy 

• Test results from the radiology department 


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• Incident reports 

• Employee health reports of injuries, needlesticks, communicable diseases, and exposures 

• Procedure and activity logs from the respiratory therapy department, operating room, and medical 
care units 

• Reports from others who review medical records, such as performance improvement personnel 

• Reports from caregivers 

• Observations of care processes 

Identify and use existing electronic databases and other sources of information. Whenever possible, 
arrange to have data downloaded directly into a computerized surveillance database so they can be 
efficiently manipulated and analyzed. Surveillance personnel can often accomplish this by working with 
an organization's information services department. 

Ensure that personnel who are responsible for collecting and managing surveillance data have adequate 
training in reviewing medical records, interpreting clinical notes, applying standardized criteria for 
identifying cases, and using appropriate statistical and risk adjustment methods. Personnel should also 
be proficient in using computer tools and technology (especially electronic records, spreadsheets, and 
databases) to collect, enter, store, manage, and analyze data. 1,2 ,3 

Collect data using standardized data collection forms. These should be designed to collect only those 
elements needed to identify a case and determine if the case criteria are met for the condition or event 
being studied.sTo facilitate rapid data collection, a form should be designed so that data elements (e.g., 

yes/no, procedures, treatments, and risk factors) can be circled, checked, or otherwise selected. Limit 
narrative entries as much as possible. The data collection forms used in the NHSN are available on the 
Internet ( www.cdc.gov/nhsn t and can be used as-is or as a guide in designing a form for a specific 
event. Whenever possible, collect data via information technology and have it downloaded into an 
accessible database. 

Design an Interpretive Surveillance Report 

Develop written reports to provide a mechanism to interpret and disseminate surveillance data and 
establish time lines for distributing the reports. Use surveillance findings to stimulate performance 
improvement activities. Tables, graphs, and charts are effective tools for organizing, summarizing, and 
visually displaying data and should be used when applicable. Tailor the format and level of detail in 
each report to the intended audience. 

A surveillance report should: 

1. Define the event, population, setting, and time period studied (e.g., SSI in patients undergoing 
coronary artery bypass graft in hospital A from January 2013 to December 2013). 

2. State the criteria used for defining a case (e.g., NHSN criteria for SSI). 

3. Specify the number of cases or events identified and the number in the population studied (e.g., 2 
SSIs in 179 coronary artery bypass graft procedures performed). 

4. Explain the methodology used to identify cases (e.g., case reports from personnel and review of 
medical records and laboratory results). 

5. Identify the statistical methods and calculations used, when appropriate (e.g., fall rate on 2 North 
in April = number of falls on 2 North in April divided by number of resident-days on 2 North in 


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April multiplied by 1,000. The April rate is 3 falls &divide; 414 resident-days &times; 1,000 = 7.2 
falls per 1,000 resident-days). 

6 . State the purpose for conducting surveillance (e.g., to identify risk factors for infection so that 
measures can be implemented to prevent infections from occurring). 

7. Interpret the findings in a manner that is understandable to those who read the report. 

8 . Describe any actions taken and recommendations made for prevention and control measures. 

9. Identify the author and date of the report. 

10. Identify the recipients of the report. 

Identify Recipients of the Surveillance Report 

Disseminate the report to those managers and healthcare providers in the organization that can use the 
findings to identify and implement evidence-based infection prevention practices and improve outcomes. 

26 


Develop a Written Surveillance Plan 

A written surveillance plan can be incorporated into an organization's infection prevention and control 
plan or can be a separate document. It should describe the following: 

• Type of healthcare setting, services provided, and populations served 

• Surveillance program purpose, goals, and objectives 

• Results of the organization's risk assessment 

• Events monitored and criteria used 

• Reason for selecting each event (outcome, process, and other) 

• Methodology used for case identification, data collection, and analysis 

• Description of applicable mandatory reporting requirements of state, federal, and other relevant 
agencies 

• Reports generated and to whom they are provided 

• Process and frequency used to evaluate the surveillance program 

SURVEILLANCE PROGRAM EVALUATION 

Periodically evaluate the surveillance program to assess its usefulness and ability to meet the 
organization's objectives, and make revisions as needed. Compare the program's structure and activities 
with current evidence-based practices and published recommendations for surveillance programs in 
similar settings. 1 , 8 , 23,26 Identify and incorporate the latest requirements of state, federal, accrediting, and 

other relevant agencies. 

A surveillance program should be able to support a system that can prevent as many infections and 
other adverse events as possible with the resources available. 

When assessing the surveillance program ask the following: 

• Does it incorporate all of the elements of an effective surveillance program described in the above 
section under Program Design? 

• Are data collected, managed, analyzed, and reported by knowledgeable personnel qualified by 
training and experience? 


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• Is the program being used to monitor and improve outcomes and processes? 

• Are the quality and accuracy of surveillance data periodically evaluated and validated? 

• Is the surveillance methodology periodically evaluated and validated? 

• Are appropriate statistical methods used when comparing data internally over time? 

• Are appropriate statistical methods used when comparing data with external benchmarks? 

• Have information technology resources been identified? 

• Is information technology being used to collect, store, manage, and analyze data as much as 
possible? 

• Has the program demonstrated that it can accomplish the following: 
o Detect infections, injuries, or other events in a timely manner 

o Identify trends signaling changes in the occurrence of an event 
° Detect outbreaks and clusters of infection 

° Identify risk factors associated with infection or other adverse event 
o Provide an estimate of the magnitude of the event being monitored 
o Assess the effectiveness of prevention and control efforts 
° Lead to improved practices by healthcare providers and other personnel 

A healthcare organization must also assess whether or not its surveillance program has adequate 
resources required to meet both the needs of the organization and the requirements of state, federal, 
and accrediting agencies. Evaluate the adequacy of the following: 

• Ability of the infection preventionist (IP) to effectively manage the program (e.g., competency, training, 
and information technology skills) 

• Number of staff to fulfill the needs of the organization 

• Personnel access to, and use of, appropriate information resources, including the organization's 
databases, email, and the Internet 

• Provision for ongoing infection prevention staff training 

• Availability of office supplies and reference materials 

• Availability of related services (e.g., secretarial, information technology, and laboratory support) 

Provide written documentation of the surveillance program evaluation, including the assessment and 
allocation of personnel and nonpersonnel resources. 

SURVEILLANCE IN NONHOSPITAL HEALTHCARE SETTINGS 

Although the majority of literature to date has focused on the acute care hospital, information on 
surveillance programs has been published for a variety of nonhospital healthcare settings: LTC,8,32,38,39, 

40,41 ambulatory surgery, 42,43,44,45,46 outpatient hemodialysis, 47,48,49,50,51 physician's offices and clinics, 

52,53,54 and home care. 55,56,57,58 Because surveillance methodologies evolve as the healthcare system 

changes, review current literature and practices before evaluating or developing a surveillance program 
in any healthcare setting. 

USING INFORMATION TECHNOLOGY 


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Information Technology and the Infection Preventionist 

The ability to use information technology—including word processing, spreadsheet, database, and 
graphics programs, the Internet, and email—is a basic requirement for the IP. At a minimum, IPs should 
subscribe to email discussion and announcement groups, such as those from the CDC, health 
departments, and professional organizations, such as the Association for Professionals in Infection 
Control and Epidemiology (APIC). These mailings inform subscribers about a variety of topics, including 
the occurrence of disease outbreaks, emerging infectious diseases, and MDROs; new and proposed 
mandatory reporting requirements; and the release of evidence-based practices for preventing 
infections. They also provide Internet links for obtaining more information, including prevention and 
control measures. Refer to the Resources section at the end of this chapter for additional information. 

IPs can also use a variety of social media to obtain and share information related to surveillance 
activities. 

Automated or Electronic Surveillance 

Automated surveillance can be defined as the process of obtaining useful information from infection 
prevention data "through the systematic application of medical informatics and computer science 
technologies." 59 Because manual methods for obtaining and evaluating the data needed to identify HAIs 

are time consuming, error prone, and labor intensive, data should be collected, managed, and analyzed 
using information technology whenever possible. 60 , 61,62 

Automated surveillance programs that use existing electronic clinical, laboratory, pharmacy, and other 
health data can improve the sensitivity, accuracy, and objectivity of surveillance and decrease the 
burden of data collection. 59,63,64,65,66 A variety of automated systems exist, including programs 

developed internally by a healthcare organization and those available commercially. 60,r63,66 CDC TAP 

reports described earlier in this chapter are an example of an electronic reporting system based on 
data collected for NHSN. 

APIC has a position paper that discusses and supports the use of automated surveillance technologies. 
60 APIC provides related information that can be accessed by entering the key words "surveillance 

technology" into the search function on the APIC home page ( www.apic.org ). 

BENCHMARKING AND COMPARING DATA 

Benchmarking is the process of comparing oneself to others that are performing similar activities for the 
purpose of improving performance. Although it is very appealing to compare one's rates externally with 
those of others, comparisons should be made only after ensuring that the following conditions are met: 

23,67 

• Criteria for defining a case are standardized and up-to-date 

• Criteria are consistently used by all participants and all data collectors 

• The population and time period for study are well defined 

• The data collection and surveillance methodology are standardized and consistently used by all 
participants over time 

• Rates and ratios are calculated using the same numerators (number of cases) and denominators 
(e.g., population at risk, device-days, patient-days) 


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• The size of the population studied (denominator) is large enough to provide an accurate estimate of 
the true rate 

• A standardized risk adjustment method is used by all participants 

• All data collectors receive training on how to collect data and use a standardized form 

• The facility and population being compared are similar to the types of facilities and populations in an 
aggregate database used for external comparison (e.g., data from a neonatal ICU is compared with 
data aggregated from other neonatal ICUs) 

• The aggregating organization has a mechanism for ensuring the accuracy, sensitivity, and specificity 
of the data submitted 

• The reports, analysis, and interpretation of the data provided by the benchmarking system are 
accurate and in a form that is understandable to the users 

• Feedback will be disseminated to those who can effect change 

• The data provided by an organization to an external aggregating system are coded for confidentiality, 
and the reports provided to the organization or to others do not contain facility identifiers unless the 
data are being used for a public reporting program 

Benchmarking and Comparative Database Systems Worldwide 

Benchmarks are measures against which outcomes and processes can be compared. There are 
currently few validated external benchmarks that can be used for interfacility comparisons of HAIs and 
other adverse events. Worldwide, efforts are under way to standardize infection surveillance criteria and 
methodology. Additional work is needed to identify useful methods to risk adjust populations studied, and 
to develop information technology to improve the ability to collect, manage, and report data and 
compare populations for benchmarking and performance improvement. 68,69,70 

In the United States, efforts have been made to establish systems for benchmarking in a variety of 
settings: acute care, 25 ,67 hemodialysis, 47,48 LTC, 38,39,40 home care, 55 . 56. 81 and ambulatory surgery. 

46 The NHSN, discussed below, is the oldest and most widely used comparative database used in the 

United States for HAIs. 

Comparing Rates 

Statistical methods should be used to compare differences between populations studied. For example, if 
a hospital uses NHSN methodology to collect and analyze surgical site infection data, then it can use 
the z-test and standardized infection ratio (SIR) to compare its risk-adjusted SSI rates with the rates in 
the NHSN System Reports. 82 . 83 The use of z-tests and the SIR to compare rates between two defined 
populations is discussed elsewhere in this text. Other statistical methods that are used to compare 
differences between populations, such as the t-test, chi-square test, Fisher's exact test, confidence 
intervals, and the 2 &times; 2 table, are also discussed elsewhere in this text. TAP Reports which 
include CAD metrics that allow facilities to compare internal unit infection rates and to compare rates 
across timeframes. 

IMPROVING PERFORMANCE, PATIENT SAFETY, AND INFECTION 
PREVENTION 

One of the main purposes for conducting surveillance is to provide information that can be used to 
target performance improvement activities. 1 . 26 . 67 There are many published reports that demonstrate 


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the use of surveillance data to identify potential problems and risk factors for infection, implement 
prevention and control measures, and document the reduction of infection rates in a variety of 
healthcare settings. 6, 67,67An effective infection prevention and control program incorporates a 

surveillance program that enhances a healthcare organization's performance improvement activities and 
reduces the risk of adverse outcomes.26 

Critical elements that have been shown to be successful in reducing infection rates include the 
followinq:67 

• Voluntary participation and confidentiality 

• Standard definitions and protocols 

• Defined populations at risk (e.g., intensive care, surgical patients) 

• Site-specific, risk-adjusted infection rates comparable across institutions 

• Adequate numbers of trained IPs 

• Dissemination of data to healthcare providers 

• A link between monitored rates and prevention efforts 16 

Since the release of the Institute of Medicine report on patient safety and medical errors in 1999, 
infection prevention and performance improvement communities have focused their attention on the role 
of infection prevention in providing a safe healthcare environment. 1_6lnfection prevention is a critical 
component of patient safety.1_6Infection prevention and patient safety activities can complement and 
benefit each other. For example, patient safety practices, such as continuous quality improvement and 
root cause analysis, can augment infection prevention and control programs. 89Root cause analysis can 
be used to review HAIs that are implicated as attributable causes of death. 86 . 89 .96Converselv. 
traditional infection prevention practices that can benefit the patient safety field include the use of 
trained professionals and "valid definitions of infection-related adverse events, standardized methods for 
detecting and reporting events, confidentiality protections, appropriate rate adjustments for institutional 
and case-mix differences, and evidence-based intervention programs."89 

THE NATIONAL HEALTHCARE SAFETY NETWORK 

In 2005, the CDC integrated three of its patient and healthcare worker surveillance systems into the 
NHSN as follows: 

• NHSN, which replaced the National Nosocomial Infections Surveillance System for HAI surveillance in 
acute care hospitals, monitors HAIs and other healthcare events (e.g., blood safety errors and 
healthcare process measures such as adherence to central line insertion practices and antimicrobial 
use).25,97 

• National Surveillance System for Health Care Workers, which monitors healthcare personnel 
immunization, tuberculin skin testing programs, and exposures to blood and body fluids, vaccine 
preventable diseases, and tuberculosis.97 

• Dialysis Surveillance Network, which is a national surveillance system that monitors bloodstream and 
vascular infections in adult and pediatric patients treated in outpatient hemodialysis centers. 48 . 49 

The NHSN provides a Web-based reporting and knowledge system for patient and healthcare personnel 
safety information, feedback of comparative data for performance improvement, and access to 
prevention tools and best practices. NHSN monitors infection-related events that include CLABSIs, 
CAUTIs, SSIs, ventilator-associated events, and C. difficile and other drug-resistant infections. The NHSN 


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website (49) provides protocols, data collection forms, training, case studies, supporting materials, and 
analysis resources. 

As of December 2012, close to 30 states use NHSN for state-specific HAI reporting 
mandates.34Hosoitals participating in the CMS Hospital Inpatient Quality Reporting Program are required 
to report HAI data to NHSN. Consequently, as of August 2013, more than 11,000 facilities use 
NHSN.34These facilities include acute care hospitals, long-term acute care hospitals, psychiatric 
hospitals, rehabilitation hospitals, outpatient dialysis centers, ambulatory surgery centers, and nursing 
homes. Hospitals and dialysis facilities comprise the majority of participating facilities, although the 
number of facility types is increasing. 

DETECTION OF HEALTHCARE-ASSOCIATED OUTBREAKS 

Only a small proportion of HAIs are related to an outbreak.8,67,1_01_ln the healthcare setting, most 

outbreaks are suspected when routine surveillance activities detect a cluster of cases, an unusual 
organism, or an apparent increase in the occurrence of an organism or event; a clinician diagnoses an 
unusual disease; or a healthcare provider or laboratory worker notices a cluster of cases. Data mining 
and electronic or automated surveillance programs can be used to detect potential outbreaks of 
infection. 102,103 

SURVEILLANCE FOR INFECTIONS ASSOCIATED WITH THE HEALTHCARE 
ENVIRONMENT 

Surveillance of Patients and Residents 

Ensure that the surveillance program monitors patients and residents for infections that are associated 
with the healthcare environment. Refer to published guidelines for the surveillance, prevention, and 
control of diseases associated with the environment, such as aspergillosis and legionellosis. 104 . 105 

Environmental Sampling 

Guidelines for environmental sampling (i.e., culturing) of the environment, including air, water, and 
environmental surfaces, have been published by the CDC and others.104,105Routine or random, 
undirected microbiological culturing of air, water, and environmental surfaces in healthcare facilities is 
not recommended. 104Culturing is indicated, however, for selected quality assurance purposes, such as 
biological monitoring of sterilizers using bacterial spores and cultures of water and dialysate in 
hemodialysis units.104,106,107 

Cultures of environmental sources may be indicated as part of an outbreak investigation if 
epidemiological data implicate an environmental source and results can be used to direct infection 
prevention decisions. 104 Environmental sampling should be conducted only under the guidance of a 
multidisciplinary team and in accordance with written protocols that define sample collection and 
culturing methods, how to interpret results, and what actions will be taken on the basis of the 
findings.104 

In the past decade, studies have implicated environmental and medical device surfaces in the 
transmission of pathogens and subsequent colonization and infection of patients. Pathogens that have 
been linked to transmission via contaminated environmental surfaces and medical equipment include 
MRSA, VRE, C. difficile , Pseudomonas aeruginosa, Acinetobacter spp., and norovirus. 108 This has led to 
an increased focus on cleaning and disinfection of these surfaces. In addition to surveillance for the 
occurrence of these organisms, many healthcare facilities conduct process surveillance to monitor 

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cleaning and disinfection protocols. Some facilities use tools such adenosine triphosphate (ATP) or 
fluorescent gel or powder as a surrogate for surveillance cultures. 109 

SURVEILLANCE FOR PUBLIC HEALTH, EMERGING INFECTIOUS DISEASES, 
AND BIOTERRORISM 

Surveillance is the key to recognizing outbreaks and new or emerging infectious diseases so that control 
measures can be instituted to contain their spread. Disease surveillance in the United States is based 
on a passive system in which healthcare providers and laboratories report unusual or reportable 
conditions to a public health department. Therefore, IPs and healthcare personnel play an integral role 
in detecting and reporting diseases of public health significance. 

Community outbreaks have been recognized after IPs and other healthcare personnel reported disease 
cases to the local health department.HOA bioterrorist event associated with the release of anthrax 
spores was first detected when an astute clinician reported a case of inhalational anthrax. 111 In the past 
two decades, healthcare providers have been instrumental in detecting and reporting emerging 
infectious diseases, such as hantavirus pulmonary syndrome, gastroenteritis caused by norovirus, 
hemolytic uremic syndrome due to Escherichia coli 0157:H7, severe acute respiratory syndrome (SARS), 
and Middle East respiratory syndrome coronavirus (MERS-CoVT 111 Community outbreaks, such as 
influenza, RSV, and SARS have affected healthcare personnel, patients, and residents of healthcare 
institutions and can disrupt and overwhelm healthcare services. 113 

IPs should subscribe to email alerts and other warning systems that can be used to monitor the 
occurrence of local, state, national, and international outbreaks and recommendations for response. 
Examples are provided in the Resource section at the end of this chapter. 

The Institute of Medicine and the CDC have published recommendations for addressing the threat of 
emerging infectious diseases and bioterrorism that include strengthening disease surveillance 
svstems. 113 . 114 , 116 . 117 Svndromic surveillance has been used to detect potential bioterrorist events 
and respiratory svndromes. 117 Advances in health information technology have prompted the CDC and 
CMS to investigate the use of current syndromic surveillance practice beyond the emergency and urgent 
care settings. 121 Many guidelines have been published for bioterrorism and pandemic response and 
planning, and these are discussed elsewhere in this text. 

There is no doubt about the interdependence of infection prevention, clinical medicine, and public 
health. 118 lndividuals who are responsible for managing surveillance programs in healthcare settings 
should ensure that sufficient resources are allocated for the surveillance of diseases of public health 
significance, including reportable conditions, emerging infectious diseases, and infections associated with 
bioterrorism. 

SURVEILLANCE FOR MULTIDRUG-RESISTANT ORGANISMS 

Antimicrobial resistance has been increasing in both healthcare-associated and community-acquired 
infections worldwide, and vancomycin resistance in S. aureus has been detected. 11_8Surveillance to 
detect MDROs has been advocated for decades, and a healthcare organization's surveillance program 
should monitor microbiology reports for the occurrence of resistant organisms of epidemiological 
importance to the facility. 125 

Surveillance cultures and other microbiologic tests, such as molecular rapid antigen detection tests, can 
also be done to monitor the incidence, prevalence, and transmission of MDROs. Once used primarily in 
outbreak investigations, the use of active surveillance testing (AST) has been recommended to identify 


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colonization of patients and residents with MDROs in select populations in nonoutbreak 
situations. 122 . 122 The use and efficacy of AST for MRSA and other MDROs in nonoutbreak situations 
have been widely debated. 129 However. AST has been shown to reduce the incidence of MRSA when 
used in defined populations in conjunction with strict adherence to other infection prevention measures, 
such as isolation precautions and hand hygiene. 130Some state agencies require AST for MRSA and 
other MDROs, and IPs must ensure that their organization complies with these requirements. 131 The 
use of AST is discussed in more detail elsewhere in this text. 

MANDATORY AND PUBLIC REPORTING 

Mandatory and public reporting initiatives significantly affect surveillance activities in healthcare 
organizations and have caused technical and resource challenges. 131 Since 2002, at least 35 states and 
Washington, DC, have enacted legislation and other mandates that require healthcare facilities to report 
data on HAIs, epidemiologically significant organisms such as MRSA, and related quality measures (e.g., 
the Surgical Care Improvement Project indicators, healthcare personnel influenza immunization, and 
hand hygiene compliance).8,134lnformation about specific reporting requirements for each state can be 

obtained from individual state quality measurement agencies and health departments and the Public 
Policy section of the APIC website at 134 . 

In addition to state mandates, since 2002 CMS has been phasing in public reporting, pay-for- 
performance, and value-based purchasing initiatives for healthcare providers. Affected healthcare 
settings include nursing homes, acute care hospitals, long-term acute care, outpatient dialysis, inpatient 
rehabilitation, and ambulatory surgery centers. Among other requirements, beginning in 2011, CMS has 
been introducing mandatory reporting of a variety of HAI events via the NHSN. Information on CMS 
requirements for NHSN submission is available on the CDC website at http://www.cdc.gov/nhsn/cms/. 

The primary goal of public reporting is to increase the quality of healthcare processes and outcomes. 

IPs must ensure that their organization accurately collects and submits the HAI-related data required by 
state and federal agencies. The IP should then assist their organization assess the findings in the 
reports released by those agencies and utilize them in its performance improvement activities. 

New Developments 

In the past decade, developments affecting surveillance programs in healthcare settings include: 

• A continuing shift from acute inpatient care to ambulatory and LTC services? 

• Decreased length of stay across the continuum of care7 

• Expanding requirements for public and mandatory reporting of data relating to HAIs9. 69 . 132 . 133 

• The successful use of surveillance data to focus performance improvement activities and to 
demonstrate reduced infection rates and increased compliance with infection prevention 
practices l 33 . 67 

• An emphasis on the use of benchmarking and statistical methods to compare infection rates between 
qroups 47 . 48 . 48 

• A culture change that promotes infection prevention, rather than infection control, aims for zero 
HAIs135 


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• Emerging and reemerging infectious diseases and organisms, such as SARS, hantavirus pulmonary 
syndrome, avian influenza, MERS-CoV, norovirus, multidrug-resistant Acinetobacter baumannii , and 
highly virulent strains of C. difficile 

• The threat of bioterrorism and the use of syndrome surveillance lll . 111 

• The application of information technology, including data mining and automated surveillance systems, 
to lessen the burden of data collection, identify HAIs, comply with HAI reporting mandates, and affect 
performance improvement activities 54 . 102 . 136 

• The effective use of surveillance data to monitor noninfectious events, such as sharps injuries and 
compliance with infection prevention protocols (e.g., hand hygiene and healthcare personnel influenza 
immunization), and to improve healthcare practices136 

• Renewed focus on the role of the healthcare environment in the transmission of infectious agents and 
the need for surveillance for these agents108,109 

• The use of AST of patients and residents to detect MDROs so that additional infection prevention 
measures can be instituted to limit their spread122,122 

• The use of information technology to rapidly transfer information on the occurrence of outbreaks, 
emerging infectious diseases, and infection prevention measures 

• CMS initiatives to implement pay-for-performance, value-based purchasing, and public reporting 
programs122 

Conclusions 

Surveillance methodology evolves in response to changes in the healthcare delivery system, the use of 
surveillance data, and diseases prevalent in the populations served. In the past decade, healthcare 
delivery has continued to shift outside of the traditional acute care hospital, resulting in a growing need 
for surveillance in other healthcare settings. The use of surveillance data has shifted from merely 
measuring clinical outcomes, such as infections, to guiding performance improvement activities and 
demonstrating improvements in both clinical outcomes and healthcare practices. The increasing 
occurrence of antimicrobial resistance worldwide, outbreaks caused by emerging and reemerging 
infectious diseases, and the threat of bioterrorism has highlighted the need for local, regional, national, 
and global surveillance systems. IPs and others who are responsible for implementing and managing 
surveillance programs in healthcare settings must ensure that their programs are based on sound 
epidemiological and statistical principles, are designed and evaluated in accordance with current 
recommendations and practices, and have the resources needed to promote quality healthcare. 

Future Trends 

Future trends that will affect surveillance programs in healthcare settings include: 

• More widespread implementation of post-discharge surveillance to monitor HAIs, especially SSIs, that 
develop after discharge140 

• The growth of national and global surveillance systems to detect antimicrobial resistance, bioterrorist 
events, naturally occurring epidemics, and emerging infectious diseases 140 

• Expanding requirements for public and mandatory reporting of data relating to HAIs 


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• Expanding use of data related to HAIs as quality indicators in pay-for-performance, value-based 
purchasing, and public reporting programs by CMS and others 

• Increased pressure from patients, government agencies, healthcare insurers, quality improvement 
organizations, healthcare providers, IPs, the media, and others for healthcare organizations to aim to 
eliminate HAIs 

• Expanded use of electronic surveillance and information technology to identify HAIs and reduce the 
burden of collecting, managing, and analyzing data 

• The use of information technology to rapidly transfer information on disease occurrence and infection 
prevention methods 

• Increased coordination of disease surveillance activities among the infection prevention, academic, 
clinical, and public health communities 

• Use of syndromic surveillance beyond the emergency and urgent care settings 
Further research is needed to: 

• Enable the development of quantitative, objective, surveillance definitions to identify HAIs, facilitate 
automation, improve comparability, and minimize gaming140 

• Identify effective methods for standardizing the processes for collecting, managing, and reporting 
surveillance data so that data can be accurately compared between organizations '!47 . 148 

• Advance the use of information technology in surveillance for HAIs and public health 148 

• Evaluate the effect of public reporting of healthcare quality data on the processes and outcomes of 
care 153 . 154 

International Perspective 

SURVEILLANCE FOR HEALTHCARE-ASSOCIATED INFECTIONS 

National surveillance programs for HAIs exist in many countries. As in the United States, infection 
prevention and infectious disease professionals in these countries are endeavoring to standardize 
infection surveillance criteria and methodology; develop risk stratification methods; improve information 
technology to collect, manage, and analyze data; and develop benchmarking and comparative database 
systems. 70,70,155 

SURVEILLANCE FOR ANTIBIOTIC-RESISTANT ORGANISMS 

MDROs are well recognized worldwide, and many countries have surveillance and control programs to 
identify their occurrence and limit their spread. However, many nations do not have surveillance or 
control programs, and global surveillance systems are needed to rapidly detect MDROs and institute 
measures to prevent further transmission.156 

SURVEILLANCE FOR OUTBREAKS AND EMERGING INFECTIOUS DISEASES 

In 2000, the World Health Organization organized the development of the Global Outbreak Alert and 
Response Network (see website at http://www.who.int/csr/outbreaknetwork/en/ ). This is a network of 
existing institutions and networks that pool resources for the rapid identification, confirmation, and 
response to outbreaks of international importance. The global outbreak of SARS in 2003 highlighted the 
need for worldwide surveillance networks. 141The rapid transmission of SARS emphasized the value of 
collaboration among the international infection prevention, clinical, and public health communities to 


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rapidly detect cases, transfer information, and identify and implement measures to control the spread of 
the disease.157 

Supplemental Resources 

PUBLICATIONS 

Centers for Disease Control and Prevention (CDC). Self-Study Course SSI978. Principles of 
Epidemiology in Public Health Practice: An Introduction to Applied Epidemiology and Biostatistics, 3rd ed. 
CDC website. 2011. Available at: http://www.cdc.gov/osels/scientific edu/ss1978/ . 

Emerging Infectious D/seasesJournal (published electronically by the CDC). Available at: 

http://www.cdc.gov/ncidod/EID/index.htm . 

Greene LR, Cain TA, Khoury R, et al. APIC position paper: the importance of surveillance technologies 
in the prevention of health care-associated infections. Am J Infect Confro/2009 Aug;37(6):510-513. 

Morbidity and Mortality Weekly Reporf(MMWR), MMWR Recommendations and Reports, MMWR 
Surveillance Summaries and MMWR Supplements( published electronically by the CDC). Available at: 

http://www.cdc.gov/mmwr/ . 

WEBSITES 

APIC ( http://www.apic.org) 

• Legislative map: Available at: http://www.apic.org/Advocacv/Legislation . 

• Public policy resources: Available at: http://apic.org/Advocacv/Government-Affairs-Resources . 

• Application of Information Systems for Infection Prevention & Control: A Select Bibliographic 
Compendium. Wright MO, Olmsted RN. June 2010 at 

http://www.apic.org/Resource /TinvMceFileManager/Practice Guidance/Survei llance-tech no log v- 

literature-references.pdf . 

Centers for Disease Control and Prevention (CDC) ( http://www.cdc.gov ) 

• Healthcare-associated infections: Available at: http://www.cdc.gov/hai . 

• National Healthcare Safety Network (NHSN) home page: Available at: http://www.cdc.gov/nhsn . 
Center for Infectious Disease Research and Policy (CIDRAP) ( http://www.cidrap.umn.edu/ ) 

• Sign up for newsletters for News and perspectives on outbreaks. 

Centers for Medicare & Medicaid Services (CMS) ( http://www.cms.gov ) 

• Quality Initiatives: Available at: http://www.cms.gov/Medicare/Qualitv-lnitiatives-Patient- 
Assessment-lnstruments/QualitvInitiativesGenlnfo/index.html . 

• Hospital Acquired Conditions (Present on Admission Indicator): Available at 

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Pavment/HospitalAcgCond/index.html? 

redirect=/HospitalAcgCond . 

World Health Organization ( http://www.who.int ) 


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• Global Outbreak Alert and Response Network: Available at: 

http://www.who.int/csr/outbreaknetwork/en . 

• Core components for infection prevention and control programmes: Assessment tools for IPC 
programmes. WHO/HSE/GAR/BDP/2011.3. Available at: 

http://www.who.int/csr/resources/publications/HSE GAR BDP 2011 3/en. 

ORGANIZATIONS PROVIDING COMPARATIVE DATABASES FOR INFECTION 
SURVEILLANCE 

These examples are for information only; citation does not imply endorsement by APIC. 

CDC NHSN: Available at: http://www.cdc.aov/nhsn . 

Missouri Alliance for Home Care (MAHC) Infection Surveillance Project: Available at: 

http://www.homecaremissouri.org/proiects/infection/index.php . 

International Quality Indicator Project: Available at: http://www.internationalaip.com . 

Vermont Oxford Network: Available at: http://www.vtoxford.org . 

RESOURCES FOR STATISTICAL MEASUREMENT 

The StatPages.net l/l/ebs/fecontains Web pages that perform statistical calculations: Available at: 

http://statpaaes.org . 

The Epi Info software program—created by the Epidemiology Program Office of the CDC. Epi Info is a 
public domain package that provides for easy form and database construction, data entry, and analysis 
with epidemiological statistics, maps, and graphs. Available at: http://www.cdc.gov/epiinfo . 

ELECTRONIC NOTIFICATION SYSTEMS 

CDC Clinician Outreach Communication Activity (COCA). Communication network developed to provide 
two-way communication between clinicians and the CDC about emerging health threats, such as 
pandemics, natural disasters, and terrorism. Subscribe at: http://emeraencv.cdc.gov/coca/about.asp . 

CDC Health Alert Network (HAN). CDC's primary method of sharing cleared information via email about 
urgent public health incidents with public information officers; federal, state, territorial, and local public 
health practitioners; clinicians; and public health laboratories. Subscribe at: 

http://emeraencv.cdc.aov/HAN/. 

FDA MedWatch. MedWatch distributes alerts on contaminated medical products, such as intravenous 
solutions, and suspected outbreaks associated with medical devices and products via the MedWatch E- 
list. Subscribe at: http://www.fda.gov/medwatch/elist.htm . 

ProMED-mail. ProMED-mail (the Program for Monitoring Emerging Diseases) is a program of the 
International Society for Infectious Diseases. A team of moderators posts reports to ProMED from 
various sources, including public health agencies, the media, local observers, and ProMED-mail 
subscribers. The ProMED program provides a platform for discussion, requests for information, and 
collaboration in outbreak investigations and prevention efforts. Subscribe at: 
http://www.promedmail.org . 


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APIC 

XrVT OF INFECTION CONTROL 
i txV I AND EPIDEMIOLOGY 


Outbreak Investigations 


Author(s): Elizabeth A. Campbell, BS, RN, CIC 
Infection Control Coordinator 

Reston Hospital Center 
Reston, VA 

Published: October 3, 2014 


Abstract 

Outbreaks of both infectious and noninfectious adverse events can occur in any healthcare setting and 
pose a threat to patient safety. Regardless of scope, investigation of a potential outbreak involves 
certain epidemiological components. Cooperation between healthcare epidemiologists, infection 
preventionists, and public health experts is important in effectively managing outbreak responses in 
healthcare settings. The ultimate goal of any outbreak investigation is to identify probable contributing 
factors and to stop or reduce the risk for future occurrences. 

Key Concepts 

• Outbreaks should be suspected when healthcare-associated infections, recovery of specific 
pathogens, or other adverse events occur above the background rate or when an unusual microbe or 
adverse event is recognized. 

• Outbreaks in healthcare settings may be due to a variety of factors, including lapses in infection 
prevention or clinical practices, contaminated or defective products or devices, and colonized or 
infected healthcare personnel. 

• Outbreaks in healthcare are often multifactorial. 

• Epidemiological investigations of a possible outbreak must be conducted in a standardized way that 
assesses the possible contributing factors. 

• Ending an outbreak involves modifying one or more of the contributing factors. 

• The goals of an outbreak investigation are to identify contributing factors to control the outbreak and 
prevent similar outbreaks in the future. 


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Background 

Outbreaks in healthcare should be suspected when healthcare-associated infections (HAIs) or adverse 
events occur above the background rate or when an unusual microbe or adverse event is recognized. 
They can occur in any healthcare setting, and it is important to remember that the onset of symptoms 
for patients involved in a healthcare-associated outbreak may occur after the patient has left the facility, 
especially in outbreaks occurring in outpatient settings. Healthcare-associated outbreaks often have 
multiple causes, but almost all are due to one or more of the following: lapses in infection prevention or 
clinical practices, colonization or infection of healthcare personnel (HCP), or defects in or contamination 
of a product or device, either at the time of production (intrinsic contamination) or during use (extrinsic 
contamination). Outbreaks in healthcare settings may also be caused by visitors who have, or are 
harboring, an infectious disease (e.g., influenza or chickenpox). 

As healthcare delivery moves increasingly to noninpatient settings, outbreaks are increasingly being 
recognized in outpatient facilities. Because these facilities often lack the healthcare epidemiology and 
infection prevention infrastructure present in inpatient, acute care hospitals and because the adverse 
events generally occur after the patient has left the facility, the detection, investigation, and control of 
outbreaks in outpatient settings is especially challenging. Likewise, the rapid introduction of new 
technologies has increased the number of potential causes of HAI outbreaks and has led to the 
recognition of items such as tissue allografts and compounded pharmaceutical products as outbreak 
sources. 

Epidemiological investigations of outbreaks should be conducted in a standardized way. Areas that must 
be assessed include the source(s), the pathogen(s), the host(s), and the mode(s) of transmission. 
Factors associated with these areas contribute to the development of the outbreak, and modification of 
one or more of these factors will end the outbreak. The goal of any outbreak investigation is to control 
the outbreak by identifying and modifying contributing factors and to develop and implement measures 
to prevent similar outbreaks in the future. This chapter assists healthcare epidemiologists and infection 
preventionists in determining when a situation should be investigated and how to conduct an 
investigation. 

Basic Principles 

OUTBREAK INVESTIGATION 

Recognition of a Potential Outbreak 

Epidemics or outbreaks are defined as an increase over the expected occurrence of an event. Given 
that definition, it is important to note that a single case of an unusual disease (e.g., postsurgical group 
A streptococcus infection, healthcare-associated Leg/one//ainfection) may constitute an outbreak. In 
some instances, small outbreaks are referred to as “clusters,” but both outbreaks and clusters require 
prompt investigation. The term “pseudo-outbreak” is generally applied to situations in which there is a 
rise in test results (e.g., positive microbiology cultures) without actual clinical disease. 

Surveillance for HAIs and adverse events can be a great aid in the recognition of outbreaks in 
healthcare settings because it provides both a baseline rate and ongoing monitoring. However, because 
outbreaks often occur in areas that are not under surveillance, most healthcare-associated outbreaks 
are recognized by observant HCP and infection preventionists. 


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Although local and state health department requirements may differ, most require reporting of possible 
healthcare-associated outbreaks as soon as they are suspected. Public health officials may also be able 
to assist in arranging or providing epidemiological and/or laboratory support. When a contaminated or 
defective product (including blood and human tissues), device, or medication is suspected as the cause 
of an outbreak, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and 
Prevention (CDC) should be notified. 

Conducting an Outbreak Investigation 

Although outbreaks are generally divided into steps for the purposes of teaching and explanation, it is 
important to remember that outbreaks generally do not unfold in a linear or orderly manner. Thus, it is 
possible that not all of the steps described in the following discussion will be applicable in all settings 
and it is possible, if not likely, that many steps might have to occur simultaneously and be repeated 
multiple times in the course of the investigation. In general, outbreak investigations can be divided into 
two major sections, the initial investigation and the follow-up investigation, each with multiple 
components. 

The primary components of the initial investigation include the following: 

• Confirming the presence of an outbreak 

• Alerting key partners about the investigation 

• Performing a literature review 

• Establishing a preliminary case definition 

• Developing a methodology for case finding 

• Preparing an initial line list and epidemic curve 

• Observing and reviewing potentially implicated patient care activities 

• Considering whether environmental sampling should be performed 

• Implementing initial control measures 

The primary components of the follow-up investigation include the following: 

• Refining the case definition 

• Continuing case finding and surveillance 

• Reviewing regularly control measures 

• Considering whether an analytic study should be performed 

Components of Initial Outbreak Investigations 

Confirming Presence of an Outbreak 

Outbreaks are defined simply as an increase over the expected occurrence of an event. When a 
possible outbreak is reported, the initial step in the investigation is to confirm that what is being reported 
indeed represents an increase in the outcome. For infectious disease outbreaks, this might be done by 
reviewing surveillance or microbiology records. For outbreaks of other adverse events, historic, 
comparative data might be more difficult to obtain. In these instances, the decision to initiate an 
outbreak investigation might be based on the general perception of clinicians about whether or not the 
current occurrence of the event exceeds the baseline. 


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Alerting Key Partners About the Investigation 

At the outset of an outbreak investigation, it is critical to inform key partners of the situation. Facility 
administration should be notified so that resources can be made available and so that risk management 
and public affairs staff can prepare to assist. The microbiology laboratory should be notified and asked 
to alert the infection preventionists or the infection prevention or epidemiology department of new 
possible cases and to save any isolates that might be related to the outbreak.i, 2 Finally, as mentioned 

previously, local, and, as appropriate, state and federal public health officials should be notified. 
Performing a Literature Review 

There are many reports summarizing outbreak investigations published in the literature, and hence a 
literature review is a critical early step in any investigation. The literature review will help identify 
possible sources that might merit further investigation and might also provide important insight into 
optimal investigative methodology. An excellent pathway for a literature review includes the National 
Library of Medicine (available at http://www.nlm.nih.aov/ ). The CDC (available at www.cdc.aov/) 
provides an abundance of information ranging from current outbreaks and immunizations to disease- 
specific subject matter. An instrumental reference tool for infection prevention and control measures can 
be found in the Control ofCommunicable Disease in Man , 19th edition.3 

Establishing an Initial Case Definition 

Develop specific criteria for the definition of a case. The initial case definition should be narrow enough 
to focus investigative efforts but broad enough to capture the majority of cases. In outbreaks of 
infectious diseases, the decision on how broad to make the case definition is often driven by the 
pathogen. Outbreaks of rare pathogens may allow for broader definitions (e.g., any case where 
Ralstoniaspecies were recovered), whereas those caused by more common pathogens will require more 
stipulations (e.g., Staphylococcus aureussurgical site infections [SSIs] following cardiac surgery). In 
outbreaks of infections, careful consideration should be given to whether or not the case definition 
should have a microbiologic component. On one hand, requiring that cases have a culture for a specific 
organism is often quite helpful in both focusing the investigation and facilitating case finding. However, in 
some instances, this requirement might also miss cases. Decisions about requiring a microbiologic 
confirmation of cases often depends on the pathogen. For example, influenza-like illness might be 
preferred to confirmed influenza, and on the clinical syndrome, for example, SSIs might be preferred to 
SSIs due to a specific pathogen at least in the initial stages of an investigation. 

Developing a Methodology for Case Finding 

A variety of sources can be used to find additional cases that might be related to the outbreak. If the 
case definition includes a laboratory result, laboratory records are a logical place to start and can 
facilitate rapid identification of possible cases. If the outbreak involves an HAI or adverse event or a 
multidrug-resistant pathogen for which the facility is performing surveillance, infection prevention and 
surveillance records can be useful for case finding. Finally, discussions with HCP in affected areas can 
also be helpful in identifying possible cases, particularly in outbreaks in which the case definition is 
primarily clinical. 

Another issue to consider in outbreaks of many healthcare pathogens is whether or not there might be 
additional patients who are colonized with only the outbreak pathogen. In those cases, examining only 
clinical culture results might underestimate case-finding efforts and could compromise control efforts if 
the colonized patients continue to serve as a reservoir for transmission. In these instances, surveillance 


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cultures might be needed to identify additional cases. However, the benefits of performing surveillance 
cultures must be weighed against the resources required. One option that can be useful is the 
performance of a single round of surveillance cultures, sometimes referred to as a “point prevalence” 
survey, which can help assess the scope of the problem and determine whether ongoing surveillance 
cultures will be needed. 

Preparing an Initial Line List and Epidemic Curve 

The line list is, perhaps, the single most important tool in any outbreak investigation, and hence merits 
considerable early discussion and effort. In general, information that can be helpful on a line list can 
include details about patient signs or symptoms (if there is the possibility that it is a pseudo-outbreak), 
medications, procedures, consults, patient locations, contact with HCP, and host factors that might have 
predisposed the patients to the adverse event under investigation. Although they are powerful tools in 
guiding investigations, developing line lists is a resource-intensive activity because it involves a review of 
a variety of different sources of information, which might include medical records, patient location 
information (admission, discharge, and transfer data), and staff interviews. Thus, it is critical to carefully 
weigh the benefits of any information to be included on the line list against the resources required to 
obtain it. One option is to create an initial simple line list with some very basic information on potential 
exposures, such as invasive procedures and hospital locations. This type of limited line list can be 
useful in helping focus subsequent investigative efforts if many of the patients do have a common 
exposure. However, it is important to remember that these preliminary line lists can sometimes be 
misleading because not every case patient may have been exposed to the common source and some 
exposures might be associated with only cases and not the actual source of the outbreak. As with any 
part of an outbreak investigation, it is important to continue to reassess the information on the line list in 
the context of all of the other information being gathered. 

Data from the line list should also be used to create an epidemic curve (see Chapter 10 General 
Principles of Epidemiology). In some instances, the shape of the epidemic curve will provide information 
that can help identify the mode of transmission. However, there are important caveats to interpreting 
epidemic curves in healthcare-associated outbreaks. First, patients may become colonized with 
organisms well before they develop clinical infections and some patients will not develop infections at all. 
Hence, the “incubation period” suggested by the line list is often misleading for many healthcare 
pathogens. Second, exposures in healthcare settings are often ongoing and organisms may be 
transmitted from patient to patient, in addition to coming from a common, contaminated source. Hence, 
the shape of the curve in a “point-source” healthcare-associated outbreak might look very different from 
that seen in a point-source outbreak of a foodborne disease. 

Observing and Reviewing Potentially Implicated Patient Care Activities 

In most outbreak investigations, it is the observations of practices that ultimately identify the cause. The 
line list is critical in helping guide both the type and location of observations that will need to be done. 
For infectious disease outbreaks, the type of pathogen and infection being investigated can also be 
important factors. For example, investigations of outbreaks of As pergilI usshould generally include careful 
review and observations of construction activities in or near patient areas. Initial observations should 
generally be free-form, that is, without a detailed observation form and should focus on practice patterns 
and workflow that deviate from good infection prevention practices and facility or unit policies. More 
detailed and focused observations tools can be developed if needed but should be informed by the free¬ 
form observations. It is also very helpful to pay careful attention to how practices might differ among 
HCP. During these observations, it is important to engage HCP in a discussion about the outbreak being 
investigated and the potential contributing factors. It is vital that the HCP understand that the 


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investigation is collaboration between them and healthcare epidemiology, not an attempt to assign 
blame. Some important questions to ask that might lead to key insights include the following: 

• Do you always do this procedure in the way I observed? Are there situations that might require that 
you do it differently? 

• Have you seen other people do it differently? 

• What are the challenges with maintaining good techniques? 

• What do you think is causing or contributing to the outbreak? 

• What procedures or medications might I be missing because they are not in the chart or are done 
infrequently? 

In addition to specific practices, observations should also review adherence to general infection 
prevention practices such as hand hygiene and compliance with transmission-based precautions. In 
addition to helping delineate the potential causes of outbreaks, these observations can also provide 
useful “teachable moments” in infection prevention and control. 

Considering Whether Environmental Sampling Should Be Performed 

In outbreaks of infectious diseases, identifying a contaminated source is often one of the most satisfying 
and definitive investigative findings. However, environmental culturing during outbreak investigations can 
also be the most frustrating, expensive, and potentially misleading aspect of an investigation. More often 
than not, these cultures are negative and leave the investigator to ask why. Was it because the item 
cultured is actually not the source of the outbreak, or because the implicated organism was there 
before, but was not there when the culture was obtained? Or perhaps because the wrong part of the 
item was sampled? Or because the technique used was not sensitive enough to detect the 
contamination? There are also important methodological challenges in both obtaining and processing 
environmental samples. For example, culture swabs used in many facilities to sample surfaces can be 
used on only small surface areas. Also, some environmental pathogens, particularly waterborne agents, 
have adapted to survive in very-low-nutrient settings and require special media to grow in the 
microbiology laboratory. Finally, the yield of surface cultures may be limited by residual disinfectants that 
must be neutralized before the sample is processed. 

Given these challenges, some important recommendations can improve the yield of environmental 
cultures as follows: 

• Perform these cultures after making the line list and doing observations so that they can focus on 
items that seem the most likely to be implicated. Environmental cultures should never be the first step 
in an outbreak investigation. 

• Before obtaining any environmental cultures, talk with microbiology laboratory personnel to determine 
whether they are able to process the cultures that will be obtained and discuss the optimal methods 
of obtaining them. 

• Culture only items that are possible vectors of transmission. 

• Culture the items that make the most sense as the likely reservoir for the organism. For example, 
outbreaks of PseudomonassbouM focus on liquid items, whereas outbreaks of Acinetobactershou\d 
focus on surfaces. 

Implementing Initial Control Measures 


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It is important to remember that the ultimate goal of any outbreak investigation is to halt the adverse 
events. Thus, it is not only acceptable, but important, to implement a variety of infection prevention 
measures throughout the course of the investigation. These control measures might be driven by 
findings from the line list and observations. For example, a strong association with a particular type of 
procedure or observations of infection prevention breaches during the procedure might lead to 
immediate alterations in the manner or facility location in which the procedure is performed or even a 
temporary cessation of the procedure. It is always appropriate to reinforce education on compliance with 
general infection prevention and control recommendations during any outbreak. In addition to making 
these initial recommendations, it is vital to develop a plan to ensure compliance with them. 

Steps of the Follow-up Investigation 

The steps in the initial investigation may need to be repeated multiple times during the course of the 
investigation. In many instances, these steps are sufficient in controlling an outbreak, and the steps of 
the “follow-up” investigation are unnecessary. However, there are instances when outbreaks persist 
despite the initial measures, in these cases, the follow-up steps can become important. 

Refining the Case Definition 

As the investigation progresses, it may be useful to refine the case definition based on the information 
gleaned from the initial cases. Ideally, the case definition should be refined to make it as focused as 
possible on detecting all cases that are potentially associated with the outbreak. This might require that 
the definition be either narrowed or expanded. 

Continuing Case Finding and Surveillance 

A methodology should be established to continue case finding efforts. This will be critical in monitoring 
the progress of the outbreak and in ensuring that it has ended. This surveillance should continue for 
some period of time (e.g., 1 month) after the outbreak has terminated to ensure that it is truly over. 

Regularly Reviewing Control Measures 

All infection prevention and control measures that are implemented as part of an outbreak investigation 
should be reviewed regularly. First and foremost, during the outbreak, compliance with the measures 
must be reviewed to ensure that recommended control measures are being carried out. In situations in 
which outbreaks persist and compliance with recommended measures is suboptimal, consideration must 
be given to how best to heighten compliance. As the outbreak begins to wane, control measures should 
be critically assessed to determine if and when they can be loosened. This is especially important for 
control measures that are very time consuming or resource intensive, such as patient-cohorting or 
dedicating staff to the care of case-patients. 

Considering Whether an Analytical Study Should Be Performed 

Analytical studies (most often case-control studies in outbreak investigations) are complicated and time 
consuming and often require access to technical and statistical support. As such, these studies 
sometimes exceed the resources available to some infection preventionists. Sometimes, an inability to 
perform an analytical study is cited as a reason that a facility cannot embark on an outbreak 
investigation without outside assistance. This should not be the case. More often than not, analytical 
studies are not necessary in the investigation and control of a healthcare-associated outbreak. Rather, 
they tend to provide statistical support to the cause or causes identified through chart review and 
observations. However, in some situations, analytical studies can be particularly useful and should be 


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considered. First, analytical studies can often help guide further investigations and suggest new avenues 
for exploration in situations in which the source of an outbreak remains unclear and control measures 
have been ineffective. Second, they might be useful in convincing clinicians that the proposed source or 
mechanism suggested by chart review and observations is indeed correct. This can be particularly 
helpful when environmental cultures do not or cannot confirm the source and when the proposed 
intervention(s) to address the source are resource intensive. Finally, analytical studies are powerful 
teaching tools and might be undertaken to further the educational experience of trainees in healthcare 
epidemiology, infection prevention, and public health. 

Communication During and After an Outbreak Investigation 

Communication within the facility and with public health officials can be critical to the success of an 
outbreak investigation. In addition to working with public health officials, as described above, there are 
several important lines of communication within the facility that must be maintained during the course of 
an investigation. 

Clinicians working in the affected areas should be kept abreast of developments and findings and should 
be queried regularly on any additional thoughts or insights they might have. Not only will this provide 
important information to help guide the investigation, but it will also help assure HCP tha